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
1825–1848 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 27, 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
K090495 · NBW
Home Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 26, 2009
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090536 · NBW
Taidoc Technology Corporation
Chemistry · 27d
Cleared Mar 24, 2009
BETACHEK GLUCOSE TEST
K062187 · NBW
National Diagnostic Products
Chemistry · 966d
Cleared Mar 23, 2009
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
K083891 · JJY
Maine Standards Co.
Chemistry · 84d
Cleared Mar 20, 2009
AVIE A1C TEST SYSTEM
K081269 · LCP
Mec Dynamics Corp
Chemistry · 319d
Cleared Mar 13, 2009
SYMCARE DIABETES MANAGEMENT PROGRAM
K083263 · NBW
Symcare Personalized Health...
Chemistry · 128d
Cleared Mar 13, 2009
EASYQC - CHEMISTRY WITH ELECTROLYTES
K080404 · JIX
Medica Corp.
Chemistry · 393d
Cleared Mar 11, 2009
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR,...
K083906 · NDY
Siemens Healthcare Diagnostics
Chemistry · 71d
Cleared Mar 11, 2009
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
K083570 · CGA
Taidoc Technology Corporation
Chemistry · 98d
Cleared Mar 09, 2009
PATHFAST HSCRP
K083412 · DCN
Mitsubishi Kagaku Iatron
Chemistry · 111d
Cleared Mar 09, 2009
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
K083339 · CIC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 117d
Cleared Feb 27, 2009
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT...
K083680 · CEM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 77d
Cleared Feb 27, 2009
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA...
K083465 · CGS
Siemens Healthcare Diagnostics
Chemistry · 95d
Cleared Feb 27, 2009
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
K083462 · JIT
Siemens Healthcare Diagnostics
Chemistry · 95d
Cleared Feb 27, 2009
GLUCODR PLUS SYSTEM, MODEL AGM-3000
K082328 · NBW
All Medicus Co., Ltd.
Chemistry · 197d
Cleared Feb 26, 2009
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · KLI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 169d
Cleared Feb 20, 2009
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
K083579 · JIX
Siemens Healthcare Diagnostics
Chemistry · 78d
Cleared Feb 20, 2009
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
K082201 · NBW
U. S. Diagnostics, Inc.
Chemistry · 199d
Cleared Feb 20, 2009
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST...
K080874 · CIX
Medica Corp.
Chemistry · 326d
Cleared Feb 20, 2009
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
K080853 · NBW
Genexel-Sein, Inc.
Chemistry · 331d
Cleared Feb 20, 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN...
K080481 · DDR
Beckman Coulter, Inc.
Chemistry · 364d
Cleared Feb 13, 2009
DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
K080636 · CGA
Hubdic Co., Ltd.
Chemistry · 344d
Cleared Feb 13, 2009
MEDTOXSCAN
K080635 · DKZ
Medtox Diagnostics, Inc.
Chemistry · 344d
Cleared Feb 10, 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A...
K083468 · NBW
I-Sens, Inc.
Chemistry · 78d