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
12649–12672 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 03, 1978
LYPOPROTEIN CHOLESTEROL TEST KIT
K780173 · JHM
Environmental Chemical Specialties
Chemistry · 90d
Cleared May 03, 1978
CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS.
K780372
Abbott Laboratories
Chemistry · 56d
Cleared May 03, 1978
LELECTIVE KINETIC SYSTEM-60
K780464 · JJE
Hycel, Inc.
Chemistry · 42d
Cleared May 03, 1978
KOVA TROL III
K780482 · JJW
Icl Scientific
Chemistry · 37d
Cleared May 03, 1978
CBR-T3 UPTAKE KIT
K780500 · KHQ
Clinical Bioresearch
Chemistry · 36d
Cleared May 03, 1978
CREATINE PHOSPHOKINASE (CPK)
K780504 · JHS
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE
K780505 · CIT
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
CARBON DIOXIDE REAGENTS
K780506 · KMS
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
K780507 · CKC
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
QUANTITOPE 125I-FOLATE RADIOASSAY KIT
K780508 · CGN
Kallestad Laboratories, Inc.
Chemistry · 34d
Cleared May 03, 1978
AUTO/STAT KIT
K780512 · CGA
Pierce Chemical Co.
Chemistry · 34d
Cleared May 03, 1978
TRANSFER PIPET
K780592
Abco Dealers, Inc.
Chemistry · 23d
Cleared Apr 28, 1978
STAC SYSTEM
K780373 · CKA
Technicon Instruments Corp.
Chemistry · 51d
Cleared Apr 28, 1978
STIKSEP-T3 KIT
K780486 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 32d
Cleared Apr 28, 1978
GAMMA STIK 125I T3 UPTAKE KIT
K780492 · CDP
Alpha Gamma Laboratory
Chemistry · 32d
Cleared Apr 24, 1978
THYRO-ZYME-T4 ASSAY KIT
K780401 · CDX
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Apr 24, 1978
SGOT/AST REAGENT SYSTEM
K780443 · CIT
American Monitor Corp.
Chemistry · 35d
Cleared Apr 19, 1978
HDL REAGENT SET FOR LIPOPROTEINS
K780389 · CHH
Worthington Biochemical Corp.
Chemistry · 40d
Cleared Apr 18, 1978
PRECIMAT GLYCEROL
K780439 · JGW
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Apr 12, 1978
AUTO. WELL TYPE GAMMA COUNTERS
K771614 · JJJ
Actus, Inc.
Chemistry · 232d
Cleared Apr 12, 1978
OREIA-T4
K780308 · CDX
Organon, Inc.
Chemistry · 48d
Cleared Apr 12, 1978
MODULAR SCANNING DENSITOMETER SYS.
K780318 · JQT
Transidyne General Corp.
Chemistry · 47d
Cleared Apr 12, 1978
GAMMA COUNTER
K780344 · JJJ
Lkb Instruments, Inc.
Chemistry · 42d
Cleared Apr 12, 1978
RIA SYS. FOR HUMAN GROWTH HORMONE
K780347 · CFL
Calbiochem-Behring Corp.
Chemistry · 41d