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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

126 results for "Ortho Diagnostic Systems, Inc."
121–126 of 126
Search insights Median review: 83d Cleared: 100% Top manufacturer: Ortho Diagnostic Systems, Inc. Lead specialty: Hematology
Cleared Sep 16, 1981
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567 · LCP
Ortho Diagnostic Systems, Inc.
Hematology · 104d
Cleared Jul 27, 1981
ORTHO SICKLE CELL CONTROLS
K811894 · GKA
Ortho Diagnostic Systems, Inc.
Hematology · 26d
Cleared Jun 12, 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467 · 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
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Feb 26, 1981
ORTHO QUANTITATIVE FIBRINOGEN ASSAY
K810058 · KQJ
Ortho Diagnostic Systems, Inc.
Hematology · 44d