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
6385–6408 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 22, 1991
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 22, 1991
TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
K914025 · CIT
Technicon Instruments Corp.
Chemistry · 74d
Cleared Nov 22, 1991
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Nov 22, 1991
CVM
K914619 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 37d
Cleared Nov 22, 1991
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
K914750 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Nov 19, 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
K912937 · CEC
Serono-Baker Diagnostics, Inc.
Chemistry · 137d
Cleared Nov 19, 1991
CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY
K914510 · JFN
Beckman Instruments, Inc.
Chemistry · 41d
Cleared Nov 19, 1991
TRACE GAMMA GT-SS REAGENT
K914731 · JQB
Trace Scientific , Ltd.
Chemistry · 29d
Cleared Nov 13, 1991
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011
K914696 · JHI
Medix Biotech, Inc.
Chemistry · 26d
Cleared Nov 08, 1991
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
K913371 · JIT
Creative Laboratory Products, Inc.
Chemistry · 102d
Cleared Nov 07, 1991
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · CGA
Lifescan, Inc.
Chemistry · 101d
Cleared Nov 07, 1991
TRIGLYCERIDES REAGENT SET
K914609 · CDT
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Nov 05, 1991
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
K913764 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807 · JFY
Em Diagnostic Systems, Inc.
Chemistry · 128d
Cleared Oct 31, 1991
SODIUM REAGENT SET
K914039 · CEI
Sterling Diagnostics, Inc.
Chemistry · 51d
Cleared Oct 30, 1991
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
K913058 · CEF
Helena Laboratories
Chemistry · 112d
Cleared Oct 30, 1991
PHOSPHOLIPID REAGENT SET
K914040 · JNT
Sterling Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 30, 1991
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
K914469 · CHH
Cholestech Corp.
Chemistry · 23d
Cleared Oct 25, 1991
VENTREX COATED TUBE INTACT PTH
K913434 · CEW
Ventrex Laboratories, Inc.
Chemistry · 85d
Cleared Oct 25, 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Oct 25, 1991
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER
K913590 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 74d
Cleared Oct 25, 1991
CIBA CORNING ACS T3 IMMUNOASSAY
K913646 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 70d
Cleared Oct 25, 1991
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240 · JHI
Unipath , Ltd.
Chemistry · 51d
Cleared Oct 23, 1991
STAMBI-CK
K913349 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 89d