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
701–725 of 3201
Cleared Jan 23, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
K063508 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 64d
Cleared Jan 22, 2007
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
K063351 · Dade Behring, Inc.
NDY · Test, Cystatin C · 77d
Cleared Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · Dade Behring, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 66d
Cleared Dec 26, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
K062924 · Dade Behring, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 89d
Cleared Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
K063543 · Roche Diagnostics Corp.
CIG · Diazo Colorimetry, Bilirubin · 28d
Cleared Nov 22, 2006
CALCIUM
K062855 · Abbott Laboratories
CJY · Azo Dye, Calcium · 58d
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 14d
Cleared Sep 22, 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 43d
Cleared Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · Instrumentation Laboratory CO
LPS · Urinary Homocystine (nonquantitative) Test System · 106d
Cleared Sep 19, 2006
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990 · Dade Behring, Inc.
DCF · Albumin, Antigen, Antiserum, Control · 68d
Cleared Sep 15, 2006
GEM PREMIER 4000 WITH IQM, MODEL 4000
K061974 · Instrumentation Laboratory CO
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 65d
Cleared Sep 15, 2006
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
K061190 · Beckman Coulter, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 140d
Cleared Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 35d
Cleared Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · Roche Diagnostics Corp.
CFR · Hexokinase, Glucose · 40d
Cleared Sep 11, 2006
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
K061802 · Dade Behring, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 76d
Cleared Sep 11, 2006
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · Dade Behring, Inc.
NBC · Test, Natriuretic Peptide · 80d
Cleared Sep 06, 2006
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · Dade Behring, Inc.
JIF · Enzymatic Method, Ammonia · 28d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
K062034 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 49d
Cleared Sep 06, 2006
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825 · Dade Behring, Inc.
DCN · System, Test, C-reactive Protein · 70d
Cleared Aug 29, 2006
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
K061839 · Dade Behring, Inc.
CIG · Diazo Colorimetry, Bilirubin · 61d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
K062122 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 31d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121 · Dade Behring, Inc.
DKB · Calibrators, Drug Mixture · 31d
Cleared Aug 25, 2006
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
K061923 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 49d
Cleared Aug 25, 2006
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR
K061719 · Dade Behring, Inc.
CIG · Diazo Colorimetry, Bilirubin · 67d
Cleared Aug 25, 2006
N LATEX CDT
K060677 · Dade Behring, Inc.
NAO · Test, Carbohydrate Deficient Transferrin · 164d

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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