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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12841–12864 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 18, 1977
CHOLESTEROL
K771833 · CGO
Gamma Enterprises, Inc.
Chemistry · 27d
Cleared Oct 14, 1977
CLINICARD CREATININE CHEMISTRY
K771773 · CGX
Harleco
Chemistry · 25d
Cleared Oct 13, 1977
EMIT THYROXINE CONTROL
K771657 · JJX
Syva Co.
Chemistry · 45d
Cleared Oct 13, 1977
INTRAVENOUS FILTER W/AUTO AIR VENT
K771826 · FPB
Jelco Laboratories
Chemistry · 24d
Cleared Oct 13, 1977
INTRAVENOUS FILTER W/FLASH BULB
K771827 · FPB
Jelco Laboratories
Chemistry · 24d
Cleared Oct 07, 1977
CARBON DIOXIDE ANALYZER
K771610 · CIE
Corning Medical & Scientific
Chemistry · 46d
Cleared Oct 07, 1977
HEMOGLOBIN A2 TESTING SYSTEM
K771649 · JBD
Isolab, Inc.
Chemistry · 39d
Cleared Sep 28, 1977
NOVA 2 IONIZED CALCIUM ANALYZER
K771643 · JFP
Nova Biomedical Corp.
Chemistry · 30d
Cleared Sep 22, 1977
T4 BY RIA DIAG. KIT
K771414 · CDX
Biomedical Labs., Inc.
Chemistry · 52d
Cleared Sep 22, 1977
PROLACTIN RIA DIAG. KIT
K771656 · JMF
Abbott Laboratories
Chemistry · 24d
Cleared Sep 20, 1977
MINISTAT-S CHEMISTRY ANALYZER
K771591 · JJI
Biokinetix Corp.
Chemistry · 32d
Cleared Sep 20, 1977
NSULIN RIA KIT 125I
K771628 · CFP
Bd Becton Dickinson Vacutainer...
Chemistry · 25d
Cleared Sep 15, 1977
AVL BLOOD GAS INSTRUMENT MODEL 939
K771147 · CHL
Jones Medical Instrument Co.
Chemistry · 80d
Cleared Sep 15, 1977
CHOLOPAP-HDL
K771586 · CHH
Advanced Biomedical Methods, Inc.
Chemistry · 28d
Cleared Sep 15, 1977
THYROID STIMULATING HORMONE
K771590 · JLW
New England Nuclear
Chemistry · 27d
Cleared Sep 15, 1977
CREATINE KINASE ISOENZYME SUBSTRATE SET
K771605 · JHX
Pfizer Pharmaceuticals
Chemistry · 24d
Cleared Sep 15, 1977
IMMUNOSPOT NEONATAL T4 TEST
K771606 · CDX
Meloy Laboratories, Inc.
Chemistry · 24d
Cleared Sep 15, 1977
A-GENT TRIGLYCERIDES
K771608 · CDT
Abbott Laboratories
Chemistry · 24d
Cleared Sep 15, 1977
ALKALINE PHOSPHATASE ISOENZY. SUB. SET
K771620 · CIN
Pfizer, Inc.
Chemistry · 21d
Cleared Sep 13, 1977
MULTISTAT III Y GT TEST
K771473
Instrumentation Laboratory CO
Chemistry · 40d
Cleared Sep 13, 1977
MULTISTAT III X-HBDH TEST
K771474 · JMK
Instrumentation Laboratory CO
Chemistry · 40d
Cleared Sep 13, 1977
MULTISTAT III ALBUMIN TEST
K771475 · CIX
Instrumentation Laboratory CO
Chemistry · 40d
Cleared Sep 13, 1977
MULTISTAT III CHOLESTEROL TEST
K771508 · CHH
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 13, 1977
MULTISTAT III URIC ACID TEST
K771509 · CDO
Instrumentation Laboratory CO
Chemistry · 39d