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
3313–3336 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 20, 2001
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
K013265 · JJY
Maine Standards Co.
Chemistry · 50d
Cleared Nov 20, 2001
BIOSCANNER 2000
K013068 · CGA
Polymer Technology Systems, Inc.
Chemistry · 145d
Cleared Nov 20, 2001
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · CFR
Bayer Corp.
Chemistry · 151d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · DFC
Roche Diagnostics Corp.
Chemistry · 52d
Cleared Nov 16, 2001
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · NBW
Polymer Technology Systems, Inc.
Chemistry · 52d
Cleared Nov 16, 2001
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
K013119 · JJX
Maine Standards Co.
Chemistry · 59d
Cleared Nov 16, 2001
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA...
K013101 · JFJ
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · CEO
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
K011586 · GAA
Diametrics Medical, Inc.
Chemistry · 177d
Cleared Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278 · DEL
Roche Diagnostics Corp.
Chemistry · 45d
Cleared Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · LCP
Dade Behring, Inc.
Chemistry · 156d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 13, 2001
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT....
K013102 · JMO
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 13, 2001
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · JIY
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 09, 2001
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372 · LCX
Unipath , Ltd.
Chemistry · 29d
Cleared Nov 09, 2001
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
K013152 · LBS
Elan Holdings, Inc.
Chemistry · 50d
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126 · JIS
Dade Behring, Inc.
Chemistry · 51d
Cleared Nov 08, 2001
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
K012326 · JGJ
Wiener Laboratories Saic
Chemistry · 108d
Cleared Nov 07, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
K012987 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 62d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373 · CEM
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Nov 02, 2001
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
K012829 · KQO
Biocare Corp.
Chemistry · 71d
Cleared Nov 02, 2001
GLYCOSAL II HBA 1C TEST
K011933 · LCP
Provalis Diagnostics , Ltd.
Chemistry · 135d
Cleared Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · KLS
Bayer Corp.
Chemistry · 24d