FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12097–12120 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 07, 1979
ELVI URIC ACID-COLORIMETRIC METHOD
K792403 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CREATININE
K792404 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ACID & PROSTATIC PHOSPHATASE
K792405 · JFH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI SERUM IRON
K792406 · CFM
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI URIC ACID
K792412 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ALKALINE PHOSPHATATASE
K792413 · CJE
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TRIGLYCERIDE
K792414 · JGY
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792415 · CIG
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TOTAL PROTEINS
K792416 · CER
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI BLOOD UREA NITROGEN
K792417 · CDL
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 06, 1979
HUMAN CHORIONIC GONADOTROPIN (RIA)
K792197 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 35d
Cleared Dec 06, 1979
CENTRIA CORTISOL RIA TEST SET
K792243 · CGR
Ventrex Laboratories, Inc.
Chemistry · 29d
Cleared Dec 06, 1979
NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE
K792254 · JFL
Nova Biomedical Corp.
Chemistry · 28d
Cleared Dec 06, 1979
AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM
K792279 · CFP
Micromedic Systems
Chemistry · 23d
Cleared Dec 06, 1979
TECHNICON C800 SYSTEM
K792285 · JJC
Technicon Instruments Corp.
Chemistry · 23d
Cleared Dec 06, 1979
TSH STANDARDS & DILUENT
K792290 · JIT
Amersham Corp.
Chemistry · 23d
Cleared Dec 06, 1979
AMES DEXTROMETER REFLECTANCE COLORIMETER
K792292 · JJQ
Miles Laboratories, Inc.
Chemistry · 23d
Cleared Dec 06, 1979
CONCEP-7-BHCG
K792308 · JHI
Leeco Diagnostics, Inc.
Chemistry · 20d
Cleared Dec 06, 1979
COULTER HDL CHOLESTEROL REAG. SYSTEM
K792319 · LBS
Coulter Electronics, Inc.
Chemistry · 17d
Cleared Dec 06, 1979
DONNECT. DIAG. CALCIUM DIAG. REAGENT
K792337 · CIC
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS
K792338 · CIG
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN
K792339 · CIX
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE
K792340 · CEK
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
TWO MINUTE PROTEINTEST
K792346 · CEK
Panmed, Inc.
Chemistry · 17d