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.

13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
726–750 of 3201
Cleared Aug 21, 2006
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K062236 · Dade Behring, Inc.
MKW · Cyclosporine · 19d
Cleared Aug 21, 2006
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128 · Dade Behring, Inc.
JHS · Differential Rate Kinetic Method, Cpk Or Isoenzymes · 26d
Cleared Aug 21, 2006
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
K061838 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 53d
Cleared Aug 16, 2006
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 20d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 42d
Cleared Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
K061750 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 51d
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 156d
Cleared Aug 07, 2006
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
K062055 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 18d
Cleared Aug 07, 2006
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793 · Dade Behring, Inc.
JIY · Photometric Method, Iron (non-heme) · 42d
Cleared Aug 02, 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
K061703 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 47d
Cleared Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · Roche Diagnostics Corp.
DDR · Myoglobin, Antigen, Antiserum, Control · 36d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 20d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 22d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 24d
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc.
LDP · Colorimetry, Acetaminophen · 27d
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 48d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 60d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · Abbott Laboratories
MMI · Immunoassay Method, Troponin Subunit · 76d
Cleared Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 25d
Cleared May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · Dade Behring, Inc.
JIS · Calibrator, Primary · 27d
Cleared May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
K061238 · Dade Behring, Inc.
KHS · Enzymatic, Carbon-dioxide · 22d
Cleared May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · Dade Behring, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 169d
Cleared May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048 · Roche Diagnostics Corp.
CFR · Hexokinase, Glucose · 30d
Cleared May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
K061020 · Dade Behring, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 27d
Cleared May 05, 2006
GLUCOSE
K060383 · Abbott Laboratories
CFR · Hexokinase, Glucose · 80d

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All categories 3201 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 55 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 51 MMI Immunoassay Method, Troponin Subunit 46 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JHI Visual, Pregnancy Hcg, Prescription Use 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38