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
11217 Chemistry devices
3076–3100 of 11217
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · Hemagen Diagnostics, Inc.
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 63d
Cleared Oct 10, 2001
WIENER LAB. CREATININA CINETICA AA
K012065 · Wiener Laboratories Saic
JFY · Enzymatic Method, Creatinine · 100d
Cleared Oct 09, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
K012509 · Phoenix Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 64d
Cleared Oct 09, 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367 · Nichols Institute Diagnostics
JIT · Calibrator, Secondary · 75d
Cleared Oct 01, 2001
BAYER ADVIA SYSTEM
K012340 · Bayer Corp.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 69d
Cleared Sep 28, 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 57d
Cleared Sep 28, 2001
RANDOX LIPOPROTEIN
K011568 · Randox Laboratories, Ltd.
JIS · Calibrator, Primary · 130d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · Roche Diagnostics Corp.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 61d
Cleared Sep 24, 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250 · Hemagen Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 69d
Cleared Sep 21, 2001
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
K012329 · Wiener Laboratories Saic
CIX · Bromcresol Green Dye-binding, Albumin · 60d
Cleared Sep 19, 2001
WIENER LAB. UREA UV CINETICA AA
K012260 · Wiener Laboratories Saic
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 63d
Cleared Sep 13, 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · Medline Industries, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 143d
Cleared Sep 12, 2001
LIQUICHEK TDM CONTROL
K012741 · Bio-Rad
DIF · Drug Mixture Control Materials · 27d
Cleared Sep 12, 2001
GLUCOMETER DEX TEST SENSOR
K012205 · Bayer Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 58d
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 57d
Cleared Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · Bio-Rad
JJT · Enzyme Controls (assayed And Unassayed) · 24d
Cleared Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · Jas Diagnostics, Inc.
KHS · Enzymatic, Carbon-dioxide · 45d
Cleared Sep 06, 2001
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
K011128 · Nichols Institute Diagnostics
CIB · Radioimmunoassay, Angiotensin I And Renin · 146d
Cleared Sep 04, 2001
MODIFICATION TO N/T PROTEIN CONTROL SL
K012468 · Dade Behring, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 33d
Cleared Aug 30, 2001
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
K012593 · Ortho-Clinical Diagnostics, Inc.
LBR · Ldl & Vldl Precipitation, Hdl · 20d
Cleared Aug 29, 2001
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
K012513 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 23d
Cleared Aug 28, 2001
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
K012431 · Bionostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 28d
Cleared Aug 27, 2001
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
K012430 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 27d
Cleared Aug 27, 2001
DIRECT BILIRUBIN REAGENT
K011972 · Intersect Systems, Inc.
CIG · Diazo Colorimetry, Bilirubin · 63d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 28d

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All categories 11217 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 462 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 299 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