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
12385–12408 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 15, 1979
SPECTROPHOTOMETER MODEL 3000
K790235 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 15, 1979
SPECTROPHOTOMETER MODEL 650-40
K790236 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 12, 1979
RIA KIT, PROLACTIN
K790003 · CFT
Cis Radiopharmaceuticals, Inc.
Chemistry · 69d
Cleared Mar 12, 1979
ACA CREATINE KINASE ISOENZYMES
K790088 · JHS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 55d
Cleared Mar 12, 1979
URIC ACID, BOUND ENZYME
K790092 · KNK
Technicon Instruments Corp.
Chemistry · 55d
Cleared Mar 12, 1979
NEPHELOMETER, MIC-2000 LASER
K790103 · JQX
Dynatech Corp.
Chemistry · 55d
Cleared Mar 12, 1979
CHORIC-SHURE
K790138 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 49d
Cleared Mar 12, 1979
REAGENT KIT, LANCER GLUCOSE
K790197 · JJF
Sherwood Medical Industries
Chemistry · 46d
Cleared Mar 02, 1979
RIA KIT, PROGESTERONE
K782009 · JLS
The Upjohn Co.
Chemistry · 91d
Cleared Mar 02, 1979
UNITEST AMYLASE
K782032 · CIW
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Mar 02, 1979
UNITEST CREATINE KINASE
K782156 · JLB
Boehringer Mannheim Corp.
Chemistry · 70d
Cleared Feb 28, 1979
RIA KIT, VITAMIN B12
K782024 · CDD
Technia Diagnostics , Ltd.
Chemistry · 85d
Cleared Feb 27, 1979
HYCEL M
K790335 · JJF
Hycel, Inc.
Chemistry · 6d
Cleared Feb 26, 1979
SERACON-N
K782039 · JIX
Bhp Diagnostix, Inc.
Chemistry · 82d
Cleared Feb 26, 1979
IEC CENTRA-7 CENTRIFUGE MODEL 2362
K782124 · JQC
Damon Corp.
Chemistry · 61d
Cleared Feb 26, 1979
SERUM, GLUTAMIC-OXALOACETIC
K790017 · CIT
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Feb 26, 1979
SERUM, URIC ACID DETERMINATION
K790019 · CDH
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Feb 22, 1979
RIA KIT, GLUCOSE
K782143 · JME
Serono Laboratories, Inc.
Chemistry · 57d
Cleared Feb 22, 1979
ACCESSORY KIT, CENTRIFICHEM
K790041 · JQW
Union Carbide Corp.
Chemistry · 45d
Cleared Feb 22, 1979
REAGENT KIT, BAKERS DIAGNOSTIC
K790044 · CGX
J.T. Baker Chemical Co.
Chemistry · 48d
Cleared Feb 22, 1979
REAGENT KIT, CHLORIDE/CARBON DIOXIDE
K790045 · JFS
J.T. Baker Chemical Co.
Chemistry · 48d
Cleared Feb 22, 1979
ANALYZER, IMPACT 200
K790072 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 42d
Cleared Feb 22, 1979
ANALYZER, IMPACT 100
K790073 · JJI
Gilford Instrument Laboratories, Inc.
Chemistry · 42d
Cleared Feb 21, 1979
ALKALINE PHOSPHATASE
K790065 · CJE
Macomb Chemical Co.
Chemistry · 37d