Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1849–1872 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Feb 06, 2009
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462 · JGS
Diamond Diagnostics, Inc.
Chemistry · 163d
Cleared Feb 03, 2009
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
K083265 · NBW
Agamatrix, Inc.
Chemistry · 90d
Cleared Feb 02, 2009
IMMULITE 2000 FREE T4
K083373 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 80d
Cleared Jan 30, 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · DCN
Alfa Wassermann Diagnostic...
Chemistry · 108d