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
12409–12432 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 15, 1979
MINI-DILUTER 2
K782130 · JQW
Dynatech Laboratories, Inc.
Chemistry · 50d
Cleared Feb 15, 1979
SERACON-LP
K782170 · JJX
Bhp Diagnostix, Inc.
Chemistry · 48d
Cleared Feb 15, 1979
SERUM, CREATININE PHOSPHOKINASE
K790015 · JHS
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Feb 15, 1979
SERUM, GLUTAMIC-PYRUVIC
K790016 · CKA
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Feb 15, 1979
SERUM, INORGANIC PHOSPHOROUS
K790021 · CEO
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Feb 08, 1979
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · JJW
Miles Laboratories, Inc.
Chemistry · 79d
Cleared Feb 08, 1979
SERACON-A
K782037 · JIX
Bhp Diagnostix, Inc.
Chemistry · 64d
Cleared Feb 08, 1979
SERACON-C
K782038 · JJY
Bhp Diagnostix, Inc.
Chemistry · 64d
Cleared Feb 08, 1979
SERACON-HDL
K782171 · JJX
Bhp Diagnostix, Inc.
Chemistry · 41d
Cleared Feb 08, 1979
SERUM, LACTIC DEHYDROGENASE
K790020 · CFJ
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Feb 08, 1979
SHAKER, MODEL SH-510
K790027 · JRQ
Sysmex Corp.
Chemistry · 36d
Cleared Feb 01, 1979
RIA KIT, IMMO PHASE
K781953 · JLW
Corning Medical & Scientific
Chemistry · 72d
Cleared Feb 01, 1979
A-GENT CK-MB
K782015 · JHW
Abbott Laboratories
Chemistry · 58d
Cleared Feb 01, 1979
EMIT THYROXINE ASSAY
K782085 · KLI
Syva Co.
Chemistry · 49d
Cleared Feb 01, 1979
DIAGNOSTIC KIT, FERRITAB-FE-59
K782159 · JJA
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Feb 01, 1979
PREGNANCY TEST KIT, DAISY 2 IN HOME
K790002 · JHJ
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Feb 01, 1979
SERUM, POTASSIUM DETERMINATION OF
K790018 · CEM
Fisher Scientific Co., LLC
Chemistry · 29d
Cleared Jan 26, 1979
RIA KIT, QUANTITOPE CORTISOL
K781903 · CGR
Kallestad Laboratories, Inc.
Chemistry · 74d
Cleared Jan 26, 1979
RIA KIT, GAMMACOAT
K782109 · CDX
Clinical Assays, Inc.
Chemistry · 38d
Cleared Jan 26, 1979
RIA KIT, RIANEN CORTISOL
K782110 · CGR
New England Nuclear
Chemistry · 38d
Cleared Jan 26, 1979
KETOSTEROID TEST, HYCEL-17
K782116 · CCY
Hycel, Inc.
Chemistry · 30d
Cleared Jan 26, 1979
GLUCOSE REAGENT SYSTEM
K782136 · CFR
American Monitor Corp.
Chemistry · 30d
Cleared Jan 26, 1979
TOTAL IRON IN SERUM
K782160 · JIY
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Jan 26, 1979
HYCEL LDH-INT TEST
K782176 · CFH
Hycel, Inc.
Chemistry · 29d