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
12121–12144 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Dec 06, 1979
MICRO LOWRY PROTEINTEST
K792347 · JGP
Panmed, Inc.
Chemistry · 17d
Cleared Dec 06, 1979
BLOOD UREA NITROGEN REAGENT
K792362 · JGZ
Connecticut Diagnostics, Ltd.
Chemistry · 15d
Cleared Dec 06, 1979
QUANTITATIVE CONTROL URINE I (HUMAN)
K792374 · JJW
Environmental Chemical Specialties
Chemistry · 10d
Cleared Dec 06, 1979
ELEVATED LIPID CONTROL
K792375 · JJY
Environmental Chemical Specialties
Chemistry · 10d
Cleared Dec 06, 1979
QUANTITATIVE CONTROL URINE II (HUMAN)
K792376 · JJW
Environmental Chemical Specialties
Chemistry · 10d
Cleared Dec 06, 1979
PRINCIPAL ANALYTE REFERENCE SERUM
K792384 · JIX
Beckman Instruments, Inc.
Chemistry · 10d