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
1777–1800 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 14, 2009
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME...
K091455 · MZV
Diazyme Laboratories
Chemistry · 88d
Cleared Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123 · JJX
Siemens Healthcare Diagnostics
Chemistry · 119d
Cleared Aug 14, 2009
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
K090332 · NBW
Arkray Factory USA, Inc.
Chemistry · 185d
Cleared Aug 06, 2009
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
K091460 · JJX
American Biological Technologies, Inc.
Chemistry · 80d
Cleared Aug 06, 2009
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS,...
K090358 · LEG
Abbott Laboratories, Inc.
Chemistry · 175d
Cleared Aug 03, 2009
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
K091333 · MRR
Alfa Wassermann, Inc.
Chemistry · 89d
Cleared Jul 31, 2009
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
K091229 · NBW
Eps Bio Technology Corp.
Chemistry · 95d
Cleared Jul 31, 2009
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 270d
Cleared Jul 27, 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS...
K090699 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 132d
Cleared Jul 23, 2009
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
K090766 · DJZ
Lifeloc Technologies, Inc.
Chemistry · 122d
Cleared Jul 17, 2009
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
K091296 · NBW
Polymap Wireless
Chemistry · 74d
Cleared Jul 17, 2009
EASYRA DLDL REAGENT, CALIBRATOR
K090734 · MRR
Medica Corp.
Chemistry · 120d
Cleared Jul 14, 2009
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
K090389 · NBW
Bestgen Biotech Corp.
Chemistry · 147d
Cleared Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · KHS
Beckman Coulter, Inc.
Chemistry · 83d
Cleared Jul 13, 2009
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
K090188 · NBW
Taidoc Technology Corporation
Chemistry · 168d
Cleared Jul 09, 2009
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
K083130 · NQL
Perkinelmer, Inc.
Chemistry · 259d
Cleared Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
K090541 · JJY
Roche Diagnostics
Chemistry · 122d
Cleared Jun 25, 2009
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
K091225 · JJY
Maine Standards Co.
Chemistry · 59d
Cleared Jun 24, 2009
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
K090109 · CGA
Epocal, Inc.
Chemistry · 160d
Cleared Jun 23, 2009
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO...
K090404 · NBW
Taidoc Technology Corporation
Chemistry · 126d
Cleared Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE...
K082340 · CGN
Roche Diagnostics Corp.
Chemistry · 308d
Cleared Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT...
K090939 · DKB
Roche Diagnostics
Chemistry · 76d
Cleared Jun 16, 2009
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
K081150 · LCX
Turklab Medical Devices, Inc.
Chemistry · 419d
Cleared Jun 11, 2009
MODIFICATION TO AVIE A1C TEST SYSTEM
K091400 · LCP
Mec Dynamics Corp
Chemistry · 30d