FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
2953–2976 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
K032089 · JJY
Roche Diagnostics Corp.
Chemistry · 23d
Cleared Jul 30, 2003
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
K031534 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 75d
Cleared Jul 30, 2003
EARLYDETECT MENOPAUSE TEST FOR FSH
K030058 · CGJ
Early Detect, Inc.
Chemistry · 204d
Cleared Jul 25, 2003
THYRO TEST
K030912 · JLW
Thryotec
Chemistry · 123d
Cleared Jul 18, 2003
DIADEXUS PLAC TEST
K030477 · NOE
Diadexus, Inc.
Chemistry · 155d
Cleared Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · KHS
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 16, 2003
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
K031890 · JJX
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jul 11, 2003
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD...
K030703 · NBW
Home Diagnostics, Inc.
Chemistry · 127d
Cleared Jul 11, 2003
AUTION JET AJ-4270 URINE ANALYZER
K030600 · KQO
International Remote Imaging Systems
Chemistry · 136d
Cleared Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · CHH
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Jul 07, 2003
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
K030076 · JKA
Biomed Personal Metabolic and...
Chemistry · 180d
Cleared Jul 03, 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843 · NBW
Medline Industries, Inc.
Chemistry · 17d
Cleared Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
K031755 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jul 03, 2003
FASTPACK FREE T4 IMMUNOASSAY
K030329 · CEC
Qualigen, Inc.
Chemistry · 153d
Cleared Jul 02, 2003
C-REACTIVE PROTEIN (CRP)
K030899 · DCN
Abbott Laboratories
Chemistry · 100d
Cleared Jul 01, 2003
MAINLINE MAXIE HCG URINE PREGNANCY TEST
K031445 · JHI
Mainline Technology, Inc.
Chemistry · 55d
Cleared Jul 01, 2003
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · JJW
Medical Analysis Systems, Inc.
Chemistry · 56d
Cleared Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · CGN
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jun 25, 2003
LIPOPROTEIN CALIBRATOR
K031682 · JIX
Bayer Healthcare, LLC
Chemistry · 26d
Cleared Jun 25, 2003
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
K031644 · JJY
Bayer Healthcare, LLC
Chemistry · 29d
Cleared Jun 25, 2003
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K031159 · JIT
Diamond Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 25, 2003
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
K030035 · JFY
Diametrics Medical, Inc.
Chemistry · 173d
Cleared Jun 23, 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K031038 · NBC
Bayer Healthcare, LLC
Chemistry · 83d