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
4777–4800 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 15, 1996
ELECSYS T3
K962508 · CDP
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Aug 15, 1996
ACA PLUS FT4 CALIBRATOR
K962594 · JIT
Dade Intl., Inc.
Chemistry · 44d
Cleared Aug 15, 1996
ACA PLUS FREE THYROXINE(FT4) METHOD
K962602 · CEC
Dade Intl., Inc.
Chemistry · 44d
Cleared Aug 15, 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
K962997 · JJY
Nova Biomedical Corp.
Chemistry · 13d
Cleared Aug 05, 1996
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
K961477 · CDT
Trace America, Inc.
Chemistry · 109d
Cleared Aug 02, 1996
CBI 7520 READER
K961183 · JJQ
Columbia Bioscience, Inc.
Chemistry · 129d
Cleared Aug 02, 1996
TECHNICON IMMUNO 1 SYSTEM
K962125 · JJE
Bayer Corp.
Chemistry · 60d
Cleared Jul 31, 1996
ORIGEN ANALYZER
K962166 · JJQ
Igen, Inc.
Chemistry · 57d
Cleared Jul 29, 1996
FACTPLUS ONE STEP PREGNANCY TEST
K962521 · LCX
Direct Access Diagnostics
Chemistry · 40d
Cleared Jul 26, 1996
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
K954968 · JIL
Tcpi, Inc.
Chemistry · 273d
Cleared Jul 26, 1996
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
K960800 · CGN
Boehringer Mannheim Corp.
Chemistry · 150d
Cleared Jul 26, 1996
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
K961807 · GLK
Ciba Corning Diagnostics Corp.
Chemistry · 77d
Cleared Jul 26, 1996
PRECISION QID BLOOD GLUCOSE TEST STRIP
K962295 · CGA
Medisense, Inc.
Chemistry · 71d
Cleared Jul 25, 1996
MLX MICROTITER PLATE LUMINOMETER
K962265 · JSE
Dynatech Laboratories, Inc.
Chemistry · 43d
Cleared Jul 23, 1996
CHEMCARD GLUCOSE TEST
K943503 · CGA
Chem-Elec, Inc.
Chemistry · 734d
Cleared Jul 23, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
K954326 · JIT
Solarcare Technologies Corp,Inc.
Chemistry · 312d
Cleared Jul 23, 1996
URIC ACID-SL ASSAY CATALOGUE NO. 237-60
K961586 · KNK
Diagnostic Chemicals , Ltd.
Chemistry · 90d
Cleared Jul 23, 1996
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219 · LCX
Phamatech
Chemistry · 43d
Cleared Jul 22, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
K954156 · KQO
Solarcare Technologies Corp,Inc.
Chemistry · 321d
Cleared Jul 22, 1996
URITEST - NITRITE IN URINE TEST
K954685 · JMT
Tcpi, Inc.
Chemistry · 285d
Cleared Jul 22, 1996
ELECSYS TSH ASSAY
K961491 · JLW
Boehringer Mannheim Corp.
Chemistry · 95d
Cleared Jul 22, 1996
DOCUMENT CARDIAC ASSAYED CONTROL
K961750 · JJY
Casco Standards
Chemistry · 77d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL TSH
K962573 · JJX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL CARDIAC
K962575 · JJY
Boehringer Mannheim Corp.
Chemistry · 21d