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
12625–12648 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 19, 1978
REAGENT SET HDL CHOLESTEROL
K780635 · CHH
Boehringer Mannheim Corp.
Chemistry · 32d
Cleared May 18, 1978
SINGLE VIAL 10 SGPT-TRIS
K780636 · CKA
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared May 12, 1978
DATA-ZYME TRIGLYCERIDE PROCEDURE
K780379 · CDT
Data Medical Associates, Inc.
Chemistry · 65d
Cleared May 12, 1978
ALT(GPT) UNI-UV, SGPT
K780462 · CKA
Sclavo, Inc.
Chemistry · 50d
Cleared May 12, 1978
AST(GOT) UNI-UV, SGOT
K780463 · CIT
Sclavo, Inc.
Chemistry · 50d
Cleared May 04, 1978
CBR-T3RIA KIT
K780499 · CDP
Clinical Bioresearch
Chemistry · 37d
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