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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11425–11448 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046
K811574 · CGS
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
K811575 · JHW
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
K811576 · CGS
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
HELENA FETAL-TEK 200 METHOD
K811588 · JHG
Helena Laboratories
Chemistry · 17d
Cleared Jun 25, 1981
POTASSIUM TEST
K811661 · CEJ
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 25, 1981
ALBUMIN TEST
K811662 · CIX
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 25, 1981
CREATININE TEST
K811664 · CGX
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 25, 1981
TOTAL PROTEIN TEST
K811673 · CEK
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 24, 1981
N-TERMINAL HPTH BY RIA
K811418 · CEW
Immuno Nuclear Corp.
Chemistry · 36d
Cleared Jun 24, 1981
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545 · DGC
Kallestad Laboratories, Inc.
Chemistry · 23d
Cleared Jun 18, 1981
KWIK-LAC BETA-LACTAMASE KITS
K811442
Windsor Laboratories, Inc.
Chemistry · 27d
Cleared Jun 18, 1981
FLEXIGRAM AUTO LOADER SYSTEM
K811525 · JJG
Electro-Nucleonics Laboratories, Inc.
Chemistry · 20d
Cleared Jun 18, 1981
DIRECT TESTOSTERONE RIA
K811536 · CDZ
Immuchem Corp.
Chemistry · 17d
Cleared Jun 18, 1981
REAGENT SET TRIGLYCERIDES
K811553 · CHI
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Jun 18, 1981
TSH-P.E.G.
K811558 · JLW
Nuclear Diagnostics, Inc.
Chemistry · 16d
Cleared Jun 16, 1981
COHERENT FLOUROTRON MASTER
K811153 · HJO
Lumenis, Inc.
Chemistry · 50d
Cleared Jun 16, 1981
NEISSERIA-KWIK
K811412 · JSX
Windsor Laboratories, Inc.
Chemistry · 28d
Cleared Jun 16, 1981
MINERALS MODIFIED MED. BASE & SOD. GLUT.
K811420 · JSI
Oxoid U.S.A., Inc.
Chemistry · 27d
Cleared Jun 12, 1981
INSTAFIL
K810795 · KPE
Instafil, Inc.
Chemistry · 81d
Cleared Jun 12, 1981
CEA DESALTING DOLUMN SEPHADEX R
K811394 · DHX
Immuno-Diagnostic Laboratories
Chemistry · 25d
Cleared Jun 12, 1981
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
K811466 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 09, 1981
ESTRIOL KIT
K811380 · CGI
Cambridge Nuclear Corp.
Chemistry · 25d