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
1681–1704 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 08, 2010
DIAZYME CYSTATIN C ASSAY
K093680 · NDY
Diazyme Laboratories
Chemistry · 132d
Cleared Apr 07, 2010
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K093441 · KXT
Siemens Healthcare Diagnostics
Chemistry · 153d
Cleared Apr 06, 2010
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673 · JGS
Medica Corp.
Chemistry · 28d
Cleared Apr 02, 2010
COBAS U411 TEST SYSTEM
K093555 · KQO
Roche Diagnostics
Chemistry · 136d
Cleared Apr 01, 2010
ELECSYS TROPONIN I CALCHECK 5
K100594 · JJX
Roche Diagnostics
Chemistry · 30d
Cleared Apr 01, 2010
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
K093506 · CGA
Taidoc Technology Corporation
Chemistry · 140d
Cleared Mar 30, 2010
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
K092849 · CEM
Epocal, Inc.
Chemistry · 195d
Cleared Mar 29, 2010
ELECSYS CK-MB CALCHECK 5
K093582 · JJX
Roche Diagnostics
Chemistry · 130d
Cleared Mar 26, 2010
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
K093941 · CGA
Taidoc Technology Corporation
Chemistry · 94d
Cleared Mar 22, 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
K093732 · JIX
Siemens Healthcare Diagnostics
Chemistry · 108d
Cleared Mar 19, 2010
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
K100293 · JIT
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 19, 2010
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL...
K093492 · JJY
Diamond Diagnostics, Inc.
Chemistry · 129d
Cleared Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
K092848 · JJX
Roche Diagnostics Corp.
Chemistry · 184d
Cleared Mar 15, 2010
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091555 · NBW
Taidoc Technology Corporation
Chemistry · 292d
Cleared Mar 12, 2010
DIDGET WORLD REPORTS
K093930 · NBW
Bayer Healthcare, LLC
Chemistry · 80d
Cleared Mar 12, 2010
LIQUICHEK OPIATE CONTROL
K093577 · DIF
Bio-Rad Laboratories
Chemistry · 114d
Cleared Mar 10, 2010
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
K093384 · JJY
Diamond Diagnostics, Inc.
Chemistry · 131d
Cleared Mar 10, 2010
INTEGRATED LABORATORY AUTOMATION SOLUTION
K091975 · CGA
Integrated Laboratory Automation...
Chemistry · 252d
Cleared Mar 05, 2010
EXL ANEM CAL, MODEL RC640
K093645 · JIX
Siemens Healthcare Diagnostics
Chemistry · 100d
Cleared Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE...
K092740 · CGN
Abbott Laboratories
Chemistry · 178d
Cleared Mar 05, 2010
NEONATAL BIOTINIDASE KIT, MODEL 3018
K090123 · NAK
Perkinelmer, Inc.
Chemistry · 408d
Cleared Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
K093700 · JJX
Roche Diagnostics Corp.
Chemistry · 93d
Cleared Mar 02, 2010
SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
K093764 · NBW
Biotest Medical Corp.
Chemistry · 85d
Cleared Feb 25, 2010
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM,...
K093592 · NBW
Taidoc Technology Corporation
Chemistry · 98d