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
12721–12744 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 01, 1978
HYDORRYBUTYRATE DEHYDROGENASE
K780042 · JMK
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Feb 01, 1978
ULTRACHEM E-GLU, MANUAL DETERM.
K780065 · CFR
Harleco
Chemistry · 20d
Cleared Jan 31, 1978
STAC SYSTEM - ADDITIONAL ANALYTES
K772352 · CGS
Technicon Instruments Corp.
Chemistry · 39d
Cleared Jan 31, 1978
ASPARTATE TRANSAMINASE
K780039 · CIT
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Jan 31, 1978
ALANINE TRANSAMINASE
K780040 · CKA
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Jan 30, 1978
LASER IMMUNONEPHELOMETRIC ANALYZER
K772361 · JQX
G.D. Searle and Co.
Chemistry · 34d
Cleared Jan 30, 1978
17-HYDROXY TEST
K772426 · CDB
Hycel, Inc.
Chemistry · 34d
Cleared Jan 30, 1978
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
K780013 · CIT
Macomb Chemical Co.
Chemistry · 27d
Cleared Jan 26, 1978
PRINTER
K772099 · JJJ
Miles Laboratories, Inc.
Chemistry · 80d
Cleared Jan 24, 1978
LDH ISOENZYME COLUMN REAGENT SET
K772356 · CEX
Worthington Biochemical Corp.
Chemistry · 28d
Cleared Jan 12, 1978
WISP MODEL 710
K772311 · CHH
Waters Assoc., Inc.
Chemistry · 24d
Cleared Jan 12, 1978
ANALYZER, CLINICAL, SYSTEM 3
K772319 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 24d
Cleared Jan 12, 1978
DENSITOMETER 18, COMPUTING, AUTO.
K772325 · JQT
Gelman Instrument Co.
Chemistry · 24d
Cleared Jan 12, 1978
URINARY 17-KETOSTERIOD/17
K772337 · CDG
Eppendorf-Brinkmann, Inc.
Chemistry · 21d
Cleared Jan 06, 1978
RSL INSULIN KIT
K772281 · CFP
Radioassay Systems Laboratories, Inc.
Chemistry · 25d
Cleared Jan 06, 1978
ACA LIPASE VERIFIERS
K772285 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 24d
Cleared Jan 05, 1978
RIA FOR SERUM THYROXINE
K771415 · CDX
Clinical Immuno-Diagnostics
Chemistry · 157d
Cleared Jan 05, 1978
CLINICARD CK-II
K772258 · CGS
Harleco
Chemistry · 27d
Cleared Jan 05, 1978
RIANEN ESTRIOL RIA KIT
K772323 · CGI
New England Nuclear
Chemistry · 17d
Cleared Jan 05, 1978
PREGNANCY TEST KIT, ANSWER
K772359 · LCX
Diagnostic Testing, Inc.
Chemistry · 9d
Cleared Dec 22, 1977
LDH ISOENZYME CONTROL
K771894 · CEX
Bio-Reagents & Diagnostics, Inc.
Chemistry · 77d
Cleared Dec 22, 1977
ALKALINE PHOSPHATASE TEST SET
K772257 · CIO
Stanbio Laboratory
Chemistry · 17d
Cleared Dec 22, 1977
PCO 2 ELECTROLYTE
K772307 · CHL
Fisher Scientific Co., LLC
Chemistry · 6d
Cleared Dec 20, 1977
PEDIATRIC THYROXINE TEST SYS. T4
K771609 · CDX
Corning Medical & Scientific
Chemistry · 120d