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
12697–12720 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 13, 1978
ULTRAZYME PLUS GOT
K780103 · CIT
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
ULTRAZYME PLUS HBD
K780104 · JMK
Harleco
Chemistry · 24d
Cleared Feb 07, 1978
ALP REAGENT SET
K780068 · CJE
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Feb 07, 1978
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080 · CFE
Corning Medical & Scientific
Chemistry · 22d
Cleared Feb 07, 1978
ULTRACHEM ALBUMIN
K780092 · CIX
Harleco
Chemistry · 20d
Cleared Feb 01, 1978
LACTATE DEHYDROGENASE
K780041 · CFJ
Beckman Instruments, Inc.
Chemistry · 23d
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