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
3289–3312 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 21, 2001
AST (SGOT)
K013698 · CIT
Jas Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 21, 2001
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
K013652 · CIC
Wiener Laboratories Saic
Chemistry · 45d
Cleared Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
K013606 · LPS
Bayer Diagnostics Corp.
Chemistry · 51d
Cleared Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
K013466 · JHO
Helena Laboratories
Chemistry · 64d
Cleared Dec 21, 2001
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106
K011953 · CGA
Wiener Laboratories Saic
Chemistry · 183d
Cleared Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
K014034 · JFL
Beckman Coulter, Inc.
Chemistry · 11d
Cleared Dec 18, 2001
MODIFICATION TO ALPHA DX SYSTEM
K014024 · MMI
First Medical, Inc.
Chemistry · 12d
Cleared Dec 18, 2001
INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907 · LCX
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 22d
Cleared Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
K013451 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 61d
Cleared Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406 · LPS
Bayer Diagnostics Corp.
Chemistry · 64d
Cleared Dec 18, 2001
DC-UIBC-CO2-CAL, MODEL SE-153
K013178 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 85d
Cleared Dec 18, 2001
RAMP MYOGLOBIN ASSAY
K012040 · DDR
Response Biomedical Corp.
Chemistry · 172d
Cleared Dec 17, 2001
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
K011323 · NHG
Salimetrics, LLC
Chemistry · 230d
Cleared Dec 14, 2001
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · MMI
Tosoh Medics, Inc.
Chemistry · 113d
Cleared Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84)...
K013992 · CEW
Nichols Institute Diagnostics
Chemistry · 9d
Cleared Dec 07, 2001
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID...
K013734 · JJY
Medical Analysis Systems, Inc.
Chemistry · 24d
Cleared Dec 06, 2001
BAYER ADVIA IMS SYSTEM
K012337 · DCN
Bayer Corp.
Chemistry · 135d
Cleared Dec 05, 2001
TCI-31 LIFELONG OVULATION TESTER
K013323 · CEP
Tci New York
Chemistry · 61d
Cleared Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · NBW
Roche Diagnostics Corp.
Chemistry · 135d
Cleared Dec 05, 2001
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 176d
Cleared Dec 04, 2001
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
K011958 · DCN
Denka Seiken'S
Chemistry · 165d
Cleared Nov 30, 2001
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA...
K011479 · CGA
Inverness Medical Innovations, Inc.
Chemistry · 200d
Cleared Nov 27, 2001
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20...
K013145 · CIT
Wiener Laboratories Saic
Chemistry · 68d
Cleared Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS),...
K013566 · CEW
Diagnostic Products Corp.
Chemistry · 25d