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
1729–1752 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 04, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K093458 · JFY
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Dec 04, 2009
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · CFR
Roche Diagnostics
Chemistry · 101d
Cleared Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
K090628 · NBW
Bayer Healthcare, LLC
Chemistry · 270d
Cleared Dec 01, 2009
LIPIDPRO SYSTEM
K090405 · NBW
Infopia Co, Ltd.
Chemistry · 285d
Cleared Nov 24, 2009
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
K092104 · CGA
Arkray Factory USA, Inc.
Chemistry · 133d
Cleared Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
K092993 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 20, 2009
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091814 · CGA
Taidoc Technology Corporation
Chemistry · 155d
Cleared Nov 19, 2009
MICRODOT XTRA
K083273 · NBW
Cambridge Sensors Limited
Chemistry · 378d
Cleared Nov 17, 2009
EASYRA MG REAGENT, MODEL 10220
K092737 · JGJ
Medica Corp.
Chemistry · 70d
Cleared Nov 17, 2009
GLUCO LAB AUTO CODING, MODEL IGM-0022
K091157 · NBW
Infopia Co, Ltd.
Chemistry · 210d
Cleared Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
K092168 · JJX
Roche Diagnostics
Chemistry · 118d
Cleared Nov 16, 2009
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
K091815 · NBW
Biotest Medical Corp.
Chemistry · 151d
Cleared Nov 13, 2009
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032 · JJY
Biosite Incorporated
Chemistry · 45d
Cleared Nov 06, 2009
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
K091914 · JJX
Bionostics, Inc.
Chemistry · 129d
Cleared Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
K092320 · JJY
Roche Diagnostics
Chemistry · 91d
Cleared Oct 26, 2009
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL...
K091413 · CHH
Alfa Wassermann, Inc.
Chemistry · 166d
Cleared Oct 23, 2009
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
K091102 · CGA
Arkray Factory USA, Inc.
Chemistry · 190d
Cleared Oct 21, 2009
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
K092887 · NBW
Eps Bio Technology Corp.
Chemistry · 30d
Cleared Oct 20, 2009
POLY-CHEM 90 GLUCOSE
K090703 · CFR
Polymedco, Inc.
Chemistry · 217d
Cleared Oct 16, 2009
ABX PENTRA TPU CAL, MODEL A11A01898
K092570 · JIT
HORIBA ABX SAS
Chemistry · 56d
Cleared Oct 16, 2009
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846 · JFJ
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K083260 · DDR
Roche Diagnostics
Chemistry · 345d
Cleared Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · JIL
Siemens Healthcare Diagnostics
Chemistry · 165d
Cleared Oct 09, 2009
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
K090653 · NBW
Arkray Factory USA, Inc.
Chemistry · 212d