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
11262 Chemistry devices
6851–6875 of 11262
Cleared Oct 13, 1988
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
K883861 · Casco Standards
JJY · Multi-analyte Controls, All Kinds (assayed) · 30d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · Ciba Corning Diagnostics Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 28d
Cleared Oct 13, 1988
VISION CREATINE KINASE
K883946 · Abbott Laboratories
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 24d
Cleared Oct 12, 1988
MODIFIED BETA QUIK STAT EIA KIT
K882895 · Pacific Biotech, Inc.
DHA · System, Test, Human Chorionic Gonadotropin · 93d
Cleared Oct 12, 1988
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS
K883792 · Catachem, Inc.
JIY · Photometric Method, Iron (non-heme) · 35d
Cleared Oct 11, 1988
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
K882736 · Amersham Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 102d
Cleared Oct 06, 1988
BLUE DOT(TM) TEST FOR PREGNANCY
K882588 · V-Tech, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 105d
Cleared Oct 06, 1988
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
K882728 · Amersham Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 97d
Cleared Oct 06, 1988
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305 · Binax, Inc.
CGJ · Radioimmunoassay, Follicle-stimulating Hormone · 63d
Cleared Oct 06, 1988
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306 · Binax, Inc.
JIT · Calibrator, Secondary · 63d
Cleared Oct 06, 1988
CHLORIDE
K883386 · Tech-Co, Inc.
CHJ · Mercuric Thiocyanate, Colorimetry, Chloride · 57d
Cleared Oct 06, 1988
MODIFIED HCG IRMA KIT
K883639 · Pacific Biotech, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 42d
Cleared Oct 06, 1988
CLEARVIEW HCG
K883777 · Unipath , Ltd.
JHI · Visual, Pregnancy Hcg, Prescription Use · 30d
Cleared Oct 03, 1988
DELFIA(TM) NEONATAL HTSH KIT
K881627 · Pharmacia, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 174d
Cleared Oct 03, 1988
QTEST PREGNANCY TEST CONTROL
K883741 · Quidel Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 32d
Cleared Sep 30, 1988
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K883124 · Amersham Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 66d
Cleared Sep 30, 1988
ISOFOR-MM (TM)
K883222 · Intl. Immunoassay Laboratories, Inc.
JHW · U.v. Method, Cpk Isoenzymes · 63d
Cleared Sep 30, 1988
CHECK-MM
K883223 · Intl. Immunoassay Laboratories, Inc.
JHS · Differential Rate Kinetic Method, Cpk Or Isoenzymes · 63d
Cleared Sep 27, 1988
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K883320 · Sherwood Medical Co.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 53d
Cleared Sep 22, 1988
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
K882907 · Amersham Corp.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 72d
Cleared Sep 22, 1988
AVL MODEL 986 ELECTROLYTE ANALYZER
K883240 · Avl Scientific Corp.
CEM · Electrode, Ion Specific, Potassium · 52d
Cleared Sep 22, 1988
QUIDEL PREGNANCY TEST CONTROL
K883316 · Quidel Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 48d
Cleared Sep 19, 1988
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · Beckman Instruments, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 54d
Cleared Sep 19, 1988
COULTER VISCOMETER II
K883503 · Coulter Electronics, Inc.
JJL · Plasma Viscometer For Clinical Use · 33d
Cleared Sep 13, 1988
TECHNICON RA-100(TM) SYSTEM
K883209 · Technicon Instruments Corp.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 46d

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All categories 11262 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 477 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 305 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 187 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