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
11244 Chemistry devices
5226–5250 of 11244
Cleared Oct 28, 1993
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
K932660 · More Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 148d
Cleared Oct 28, 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · Baxter Diagnostics, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 134d
Cleared Oct 28, 1993
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K933026 · Synermed, Inc.
CIG · Diazo Colorimetry, Bilirubin · 128d
Cleared Oct 28, 1993
GENZYME A-AMYLASE TEST REAGENT
K933397 · Genzyme Corp.
JFJ · Catalytic Methods, Amylase · 108d
Cleared Oct 28, 1993
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
K933437 · Baxter Diagnostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 106d
Cleared Oct 22, 1993
PROGESTERONE RADIOIMMUNOASSAY KIT
K931228 · Immunotech Corp.
JLS · Radioimmunoassay, Progesterone · 226d
Cleared Oct 22, 1993
AIA-PACK(R) PROG ASSAY
K933269 · Tosoh Medics, Inc.
JLS · Radioimmunoassay, Progesterone · 108d
Cleared Oct 22, 1993
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329 · King Diagnostics, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 106d
Cleared Oct 22, 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
K933464 · Baxter Diagnostics, Inc.
CHP · Radioimmunoassay, Estradiol · 98d
Cleared Oct 22, 1993
SIGMA ELECTROLYTE BUFFER
K933695 · Sigma Chemical Co.
JFL · Ph Rate Measurement, Carbon-dioxide · 85d
Cleared Oct 22, 1993
VISTA FOLATE ASSAY
K934121 · Syva Co.
CGN · Acid, Folic, Radioimmunoassay · 58d
Cleared Oct 21, 1993
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
K934357 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 43d
Cleared Oct 18, 1993
OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp.
CIJ · Saccharogenic, Amylase · 217d
Cleared Oct 18, 1993
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
K932768 · Helena Laboratories
JIX · Calibrator, Multi-analyte Mixture · 132d
Cleared Oct 18, 1993
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · Sigma Diagnostics, Inc.
CDX · Radioimmunoassay, Total Thyroxine · 123d
Cleared Oct 18, 1993
SIGMA CRE REAGENT
K933697 · Sigma Chemical Co.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 81d
Cleared Oct 18, 1993
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3
K934056 · Medical Analysis Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 60d
Cleared Oct 14, 1993
AVL 9110PH ANALYZER
K932642 · Avl Scientific Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 134d
Cleared Oct 14, 1993
CHEMSTRIP SUPER UA URINE ANALYZER
K934042 · Boehringer Mannheim Corp.
KQO · Automated Urinalysis System · 56d
Cleared Oct 14, 1993
BECKMAN HDL CHOLESTEROL REAGENT
K934045 · Beckman Instruments, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 56d
Cleared Oct 13, 1993
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
K933693 · Sigma Chemical Co.
JIX · Calibrator, Multi-analyte Mixture · 76d
Cleared Oct 13, 1993
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM
K933955 · E.I. Dupont DE Nemours & Co., Inc.
JIX · Calibrator, Multi-analyte Mixture · 62d
Cleared Oct 12, 1993
IL TEST GLUCOSE
K931402 · Instrumentation Laboratory CO
CFR · Hexokinase, Glucose · 207d
Cleared Oct 12, 1993
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
K933386 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GIM · Tubes, Vacuum Sample, With Anticoagulant · 92d
Cleared Oct 12, 1993
ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
K933862 · Schiapparelli Biosystems, Inc.
JGS · Electrode, Ion Specific, Sodium · 64d

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All categories 11244 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 473 JJX Single (specified) Analyte Controls (assayed And Unassayed) 387 CGA Glucose Oxidase, Glucose 302 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 249 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