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
3337–3360 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 24, 2001
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · JJX
Bionostics, Inc.
Chemistry · 34d
Cleared Oct 22, 2001
BIOSCANNER PLUS
K013173 · CHH
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130 · JJX
Dade Behring, Inc.
Chemistry · 29d
Cleared Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
K013235 · JJY
Beckman Coulter, Inc.
Chemistry · 18d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900 · JIT
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Oct 16, 2001
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
K012878 · JIS
Thermo Dma, Inc.
Chemistry · 49d
Cleared Oct 16, 2001
POLY STAT HCG TEST
K012559 · JHI
Bion Diagnostic Sciences
Chemistry · 69d
Cleared Oct 15, 2001
MODIFICATION TO ALPHA DX SYSTEM
K013118 · JHX
First Medical, Inc.
Chemistry · 27d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 10, 2001
UNIMARK HCG COMBO PREGNANCY TEST
K013194 · JHI
Biotech Atlantic, Inc.
Chemistry · 15d
Cleared Oct 10, 2001
WIENER LAB. CREATININA CINETICA AA
K012065 · JFY
Wiener Laboratories Saic
Chemistry · 100d
Cleared Oct 09, 2001
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
K012518 · CJE
Thermo Dma, Inc.
Chemistry · 64d
Cleared Oct 09, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION...
K012509 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 64d
Cleared Oct 09, 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367 · JIT
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Oct 09, 2001
PHEM-ALERT
K012230 · LNW
Femtek,Llc.
Chemistry · 85d
Cleared Oct 04, 2001
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
K012525 · LCP
Thermo Dma, Inc.
Chemistry · 59d
Cleared Oct 03, 2001
ATAC PAK CPK REAGENT KIT
K012474 · CGS
Elan Holdings, Inc.
Chemistry · 62d
Cleared Oct 01, 2001
BAYER ADVIA SYSTEM
K012340 · JMO
Bayer Corp.
Chemistry · 69d
Cleared Sep 28, 2001
LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
K012907 · DIF
Clinical Controls
Chemistry · 30d
Cleared Sep 28, 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470 · JIX
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 28, 2001
RANDOX LIPOPROTEIN
K011568 · JIS
Randox Laboratories, Ltd.
Chemistry · 130d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · JIL
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Sep 26, 2001
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K011970 · CHH
Biosafe Laboratories, Inc.
Chemistry · 93d