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.

13237
Total
13205
Cleared
181d
Avg (2y)
1976
Since
11222 Chemistry devices
3501–3525 of 11222
Cleared May 25, 1999
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
K991108 · A.P. Total Care, Inc.
KHS · Enzymatic, Carbon-dioxide · 54d
Cleared May 25, 1999
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02
K990981 · A.P. Total Care, Inc.
CFR · Hexokinase, Glucose · 63d
Cleared May 25, 1999
BUN, MODEL BU 104-01
K990980 · A.P. Total Care, Inc.
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 63d
Cleared May 25, 1999
ALBUMIN BCG, MODEL AL 103-01
K990978 · A.P. Total Care, Inc.
CJW · Bromcresol Purple Dye-binding, Albumin · 63d
Cleared May 21, 1999
BAYER ADVIA 1650 CHEMISTRY SYSTEM
K990346 · Bayer Corp.
JGS · Electrode, Ion Specific, Sodium · 106d
Cleared May 21, 1999
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K984261 · Lifescan, Inc.
CGA · Glucose Oxidase, Glucose · 175d
Cleared May 19, 1999
ELAN ALKALINE PHOSPHATE REAGENT KIT
K991387 · Elan Holdings, Inc.
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 28d
Cleared May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
K991182 · Dade Behring, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 42d
Cleared May 19, 1999
VACUTAINER BRAND CTAD TUBE (MULTIPLE)
K991120 · Becton Dickinson Vacutainer Systems
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 47d
Cleared May 19, 1999
ACP
K991010 · Abbott Diagnostics Mfg., Inc.
CKB · Acid Phosphatase, Naphthyl Phosphate · 54d
Cleared May 11, 1999
AIA-PACK FT3 ASSAY
K991252 · Tosoh Medics, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 28d
Cleared May 11, 1999
CALCITONIN
K990073 · Kmi Diagnostics, Inc.
JKR · Radioimmunoassay, Calcitonin · 120d
Cleared May 10, 1999
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
K991369 · Germaine Laboratories, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 20d
Cleared May 10, 1999
ATLAST GLUCOSE CONTROL SOLUTION
K991075 · Amira Medical, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 40d
Cleared May 10, 1999
SAS ONE-STEP PREGNANCY
K990741 · Sa Scientific, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 63d
Cleared May 10, 1999
MODIFICATION OF SAS SERUM/URINE HCG
K990684 · Sa Scientific, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 68d
Cleared May 04, 1999
SAS HCG-CHECK
K991193 · Sa Scientific, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 26d
Cleared Apr 29, 1999
IN TOUCH DIABETES MANAGEMENT SOFTWARE
K984527 · Lifescan, Inc.
CGA · Glucose Oxidase, Glucose · 129d
Cleared Apr 28, 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · Phamatech
JHI · Visual, Pregnancy Hcg, Prescription Use · 27d
Cleared Apr 27, 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · Diagnostic Products Corp.
DDR · Myoglobin, Antigen, Antiserum, Control · 13d
Cleared Apr 27, 1999
MODIFICATION OF: DAVIDSTRIP HCG
K991067 · Simex Medical, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 28d
Cleared Apr 27, 1999
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
K990971 · Medica Corp.
JJR · Electrolyte Controls (assayed And Unassayed) · 35d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 62d
Cleared Apr 20, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K990939 · Selfcare, Inc.
CGA · Glucose Oxidase, Glucose · 29d
Cleared Apr 20, 1999
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · Diagnostic Chemicals , Ltd.
KHS · Enzymatic, Carbon-dioxide · 43d

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All categories 11222 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 463 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 301 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 157 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143