FDA Review Panel · CH

FDA 510(k) Chemistry Devices

FDA 510(k) Chemistry Devices - Regulatory Overview

FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.

This category includes:

  • Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
  • Point-of-care test systems - rapid diagnostics for hospital and home use
  • Reagents and calibrators - consumables used with automated analyzers
  • Urinalysis systems - dipstick readers and urine sediment analyzers

Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
2401–2425 of 13257
Cleared Mar 09, 2006
LIBERTY GLUCOSE CONTROL SOLUTION
K060481 · Liberty Healthcare Group, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 14d
Cleared Mar 09, 2006
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
K060426 · Liberty Healthcare Group, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 16d
Cleared Mar 09, 2006
THE EMIT 2000 TACROLIMUS CALIBRATORS
K060371 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 24d
Cleared Mar 09, 2006
DIMENSION IRON CALIBRATOR
K060266 · Dade Behring, Inc.
JIS · Calibrator, Primary · 36d
Cleared Mar 09, 2006
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
K053553 · Polymedco, Inc.
DCF · Albumin, Antigen, Antiserum, Control · 79d
Cleared Mar 09, 2006
ACCUREX GLUCOSE TEST STRIP
K052207 · Incline Medical, LLC
CGA · Glucose Oxidase, Glucose · 209d
Cleared Mar 09, 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · Abbott Diabetes Care, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 245d
Cleared Mar 08, 2006
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264 · Dade Behring, Inc.
JIY · Photometric Method, Iron (non-heme) · 35d
Cleared Mar 03, 2006
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
K053531 · Dade Behring, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 74d
Cleared Mar 02, 2006
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
K050975 · Nano-Ditech Co.
MMI · Immunoassay Method, Troponin Subunit · 318d
Cleared Mar 01, 2006
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
K060420 · Scantibodies Laboratory, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 12d
Cleared Mar 01, 2006
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
K053312 · Bioptik Technology, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 93d
Cleared Mar 01, 2006
MYSET PREGNANCY TEST
K053138 · Ani Biotech OY
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 112d
Cleared Feb 27, 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · Scantibodies Laboratory, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 17d
Cleared Feb 27, 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
K060256 · Beckman Coulter, Inc.
CFR · Hexokinase, Glucose · 26d
Cleared Feb 27, 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090 · Dade Behring, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 46d
Cleared Feb 21, 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K053635 · Bionime Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 54d
Cleared Feb 17, 2006
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
K060019 · Artron Laboratories, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 44d
Cleared Feb 17, 2006
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
K053253 · Hemocue AB
KQO · Automated Urinalysis System · 88d
Cleared Feb 16, 2006
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
K060133 · Inverness Medical Innovations, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Feb 16, 2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
K060108 · Roche Diagnostics Corp.
CGZ · Electrode, Ion-specific, Chloride · 34d
Cleared Feb 16, 2006
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
K053108 · Dade Behring, Inc.
DLJ · Calibrators, Drug Specific · 104d
Cleared Feb 15, 2006
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
K053566 · Diazyme Laboratories
MZV · Test, System, Potassium, Enzymatic Method · 55d
Cleared Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
K053603 · Roche Diagnostics Corp.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 48d
Cleared Feb 09, 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · Clinical Data, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 141d

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162