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
6673–6696 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 23, 1991
FLAGEN TRIIODOTHYRONINE (T3) ASSAY
K905656 · CDP
Cyberfluor, Inc.
Chemistry · 37d
Cleared Jan 23, 1991
GEN-PROBE LUMINOMETER-LEADER 450
K905762 · JJQ
Gen-Probe, Inc.
Chemistry · 27d
Cleared Jan 17, 1991
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
K904468 · CIG
Amresco, Inc.
Chemistry · 108d
Cleared Jan 17, 1991
SHBG IRMA KIT
K905247 · CDZ
Ventrex Laboratories, Inc.
Chemistry · 57d
Cleared Jan 17, 1991
CREATINE KINASE UV REAGENT SET
K905588 · JHW
Biochemical Trade, Inc.
Chemistry · 35d
Cleared Jan 17, 1991
ECLIPSE ICA TRIGLYCERIDES
K905601 · CDT
Biotope, Inc.
Chemistry · 35d
Cleared Jan 16, 1991
ECLIPSE ICA BUN
K905602 · CDQ
Biotope, Inc.
Chemistry · 34d
Cleared Jan 15, 1991
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
K903733 · LBR
Institute For Clinical Applications
Chemistry · 152d
Cleared Jan 15, 1991
GLYC-AFFIN(TM)-GA
K905513 · LCP
Isolab, Inc.
Chemistry · 36d
Cleared Jan 15, 1991
CIBA CORNING ACS T4 IMMUNOASSAY
K905532 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 36d
Cleared Jan 15, 1991
TECHLYTE ELECTROLYTE ANALYZER
K905600 · JGS
Technalysis, Inc.
Chemistry · 32d
Cleared Jan 15, 1991
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
K905659 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Jan 11, 1991
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER
K905215 · JJQ
Cirrus Diagnostics, Inc.
Chemistry · 52d
Cleared Jan 04, 1991
ECLIPSE ICA GLUCOSE
K905144 · CFR
Biotope, Inc.
Chemistry · 50d
Cleared Jan 04, 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
K905662 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Dec 28, 1990
ALKALINE PHOSPHATASE
K905684 · CJE
Amresco, Inc.
Chemistry · 9d
Cleared Dec 27, 1990
MAGNESIUM REAGENT
K905544 · JGJ
Amresco, Inc.
Chemistry · 16d
Cleared Dec 27, 1990
AFFINITY FSH TEST SYSTEM
K905592 · CGJ
Bd Becton Dickinson Vacutainer...
Chemistry · 14d
Cleared Dec 26, 1990
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST
K903126 · CHH
Crystal Diagnostics, Inc.
Chemistry · 163d
Cleared Dec 26, 1990
STATPAL BLOOD GAS MONITORING SYSTEM
K903965 · CHL
Ppg Industries, Inc.
Chemistry · 120d
Cleared Dec 26, 1990
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081 · CGA
Heraeus Kulzer, Inc.
Chemistry · 112d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082 · CGA
Cholestech Corp.
Chemistry · 112d
Cleared Dec 26, 1990
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767 · JIX
Analytical Control Systems, Inc.
Chemistry · 65d
Cleared Dec 26, 1990
GLYC-AFFIN GP
K904814 · LCP
Isolab, Inc.
Chemistry · 63d