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
1945–1968 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 30, 2008
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE...
K072854 · NBW
Tyson Bioresearch, Inc.
Chemistry · 269d
Cleared Jun 27, 2008
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
K080283 · NBW
Taidoc Technology Corporation
Chemistry · 144d
Cleared Jun 27, 2008
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
K073537 · MQM
Siemens Medical Solutions Diagnostics
Chemistry · 193d
Cleared Jun 26, 2008
S-TEST C02
K073223 · KHS
Alfa Wassermann Diagnostic...
Chemistry · 224d
Cleared Jun 26, 2008
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
K072142 · CKF
Alfa Wassermann Diagnostic...
Chemistry · 329d
Cleared Jun 25, 2008
SENTINEL PLASMAPROTEINS CAL 3X
K081533 · JIX
SENTINEL CH. SpA
Chemistry · 23d
Cleared Jun 24, 2008
S-TEST CA
K072356 · CJY
Alfa Wassermann Diagnostic...
Chemistry · 307d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
K072141 · CEO
Alfa Wassermann Diagnostic...
Chemistry · 327d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140 · CFR
Alfa Wassermann Diagnostic...
Chemistry · 327d
Cleared Jun 23, 2008
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
K081144 · NBW
Taidoc Technology Corporation
Chemistry · 62d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C...
K080811 · NDY
Roche Diagnostics Corp.
Chemistry · 88d
Cleared Jun 19, 2008
MULTIGENT CREATININE (ENZYMATIC) ASSAY
K073634 · JFY
SENTINEL CH. SpA
Chemistry · 176d
Cleared Jun 13, 2008
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
K073416 · CGA
Arkray Factory USA, Inc.
Chemistry · 193d
Cleared Jun 09, 2008
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
K081318 · NBW
Lifescan, Inc.
Chemistry · 28d
Cleared Jun 09, 2008
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K080014 · NBW
Taidoc Technology Corporation
Chemistry · 158d
Cleared Jun 06, 2008
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
K080384 · NDY
The Binding Site, Ltd.
Chemistry · 114d
Cleared Jun 06, 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269 · NBC
Biosite Incorporated
Chemistry · 126d
Cleared Jun 02, 2008
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3
K080973 · JJY
Cliniqa Corporation
Chemistry · 59d
Cleared May 29, 2008
UREA/BUN, SCAL, NORTROL, ABTROL
K073295 · CDQ
Thermofisher Scientific OY
Chemistry · 188d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF...
K081074 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared May 23, 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618 · LCP
Jas Diagnostics, Inc.
Chemistry · 79d
Cleared May 23, 2008
URIC ACID (AOX), SCAL, NORTROL, ABTROL
K073612 · JIX
Thermofisher Scientific OY
Chemistry · 154d
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT...
K080578 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 74d