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.
13234
Total
13203
Cleared
199d
Avg (2y)
1976
Since
8200 Chemistry devices
Cleared
Jul 26, 2013
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Jul 18, 2013
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
31d
Cleared
Jul 17, 2013
COBAS C BILIRUBIN TOTAL GEN.3
CIG
Diazo Colorimetry, Bilirubin
49d
Cleared
Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
JIT
Calibrator, Secondary
28d
Cleared
Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
MMI
Immunoassay Method, Troponin Subunit
417d
Cleared
Jun 07, 2013
DIAZYME MYOGLOBIN
DDR
Myoglobin, Antigen, Antiserum, Control
179d
Cleared
May 31, 2013
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
39d
Cleared
May 31, 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
CDT
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
109d
Not Cleared
May 23, 2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
PDJ
Hemoglobin A1c Test System
59d
Cleared
May 21, 2013
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
JGS
Electrode, Ion Specific, Sodium
168d
Cleared
May 16, 2013
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
139d
Cleared
May 15, 2013
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
LPS
Urinary Homocystine (nonquantitative) Test System
146d
Cleared
May 06, 2013
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
JJY
Multi-analyte Controls, All Kinds (assayed)
28d
Cleared
Apr 29, 2013
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
JJY
Multi-analyte Controls, All Kinds (assayed)
40d
Cleared
Apr 26, 2013
AUDIT MICROCV VITAMIN D LINEARITY SET
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
37d
Cleared
Apr 26, 2013
ABBOTT PHENOBARBITAL ASSAY
DLZ
Enzyme Immunoassay, Phenobarbital
189d
Cleared
Apr 19, 2013
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
241d
Cleared
Apr 05, 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
JIT
Calibrator, Secondary
22d
Cleared
Apr 05, 2013
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
39d
Cleared
Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
NBW
System, Test, Blood Glucose, Over The Counter
186d
Cleared
Apr 04, 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
LFR
Glucose Dehydrogenase, Glucose
212d
Cleared
Apr 04, 2013
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
CEC
Radioimmunoassay, Free Thyroxine
275d
Cleared
Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
45d
Cleared
Mar 21, 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
CEW
Radioimmunoassay, Parathyroid Hormone
258d
Cleared
Mar 19, 2013
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
55d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices