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.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
Cleared
Aug 08, 2007
MISSION OLYMPUS AU ISE CALIBRATORS
JIT
Calibrator, Secondary
118d
Cleared
Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
NBC
Test, Natriuretic Peptide
36d
Cleared
Aug 03, 2007
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
JFY
Enzymatic Method, Creatinine
141d
Cleared
Jul 30, 2007
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
49d
Cleared
Jul 30, 2007
COBAS C 111 ANALYZER
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
90d
Cleared
Jul 30, 2007
ACON U120 URINE ANALYZER, MODEL U111-101
KQO
Automated Urinalysis System
118d
Cleared
Jul 23, 2007
ONE STEP HCG PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
315d
Cleared
Jul 20, 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
JIX
Calibrator, Multi-analyte Mixture
18d
Cleared
Jul 20, 2007
JAZZ BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
60d
Cleared
Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
CEW
Radioimmunoassay, Parathyroid Hormone
121d
Cleared
Jul 13, 2007
TRILOGY ANALYZER
CGA
Glucose Oxidase, Glucose
122d
Cleared
Jul 13, 2007
I-CHROMA CRP TEST
DCN
System, Test, C-reactive Protein
287d
Cleared
Jul 13, 2007
POINTE 360
CFR
Hexokinase, Glucose
353d
Cleared
Jul 11, 2007
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
CGA
Glucose Oxidase, Glucose
97d
Cleared
Jul 03, 2007
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
NBW
System, Test, Blood Glucose, Over The Counter
322d
Cleared
Jun 29, 2007
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
JHI
Visual, Pregnancy Hcg, Prescription Use
79d
Cleared
Jun 29, 2007
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
JHI
Visual, Pregnancy Hcg, Prescription Use
88d
Cleared
Jun 29, 2007
POLYMAP PWR-08-03
NBW
System, Test, Blood Glucose, Over The Counter
122d
Cleared
Jun 28, 2007
SMS GLUCOSE CONTROL, MODEL 2120059
JJY
Multi-analyte Controls, All Kinds (assayed)
36d
Cleared
Jun 25, 2007
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
LCP
Assay, Glycosylated Hemoglobin
91d
Cleared
Jun 25, 2007
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
229d
Cleared
Jun 22, 2007
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
119d
Cleared
Jun 22, 2007
ENZYMATIC CREATININE ASSAY (265 SERIES)
JFY
Enzymatic Method, Creatinine
133d
Cleared
Jun 21, 2007
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
73d
Cleared
Jun 21, 2007
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
NBW
System, Test, Blood Glucose, Over The Counter
78d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices