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

Filters: Immunology ×
3,792 results
3145–3168 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 24, 1983
ANTI N DNA-HCP
K830652 · KTL
Immuno-Products Industries
Immunology · 17d
Cleared Mar 17, 1983
MONO SCREENING TEST
K830531 · KTN
Tago, Inc.
Immunology · 27d
Cleared Mar 09, 1983
AFT SYSTEM III
K830214 · DHN
Calbiochem-Behring Corp.
Immunology · 44d
Cleared Mar 09, 1983
ROENTGENOGRAPHY SET
K830229 · DGD
Mallinckrodt Critical Care
Immunology · 44d
Cleared Mar 01, 1983
DENSITOMETRIC INHALENT PROFILE SLLER
K830164 · DGC
Mast Immunosystems
Immunology · 42d
Cleared Feb 25, 1983
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE
K823593 · DHB
Mast Immunosystems
Immunology · 81d
Cleared Feb 18, 1983
BIOCELL SPINAL FLUID CONTROL
K830179 · JJY
Biocell Laboratories, Inc.
Immunology · 31d
Cleared Feb 15, 1983
CETUS CMV IHA
K822965 · LJO
Cetus Corp.
Immunology · 131d
Cleared Feb 10, 1983
SALMONELLA-SHIGELLA AGAR
K830065 · JSI
bioMerieux, Inc.
Immunology · 30d
Cleared Feb 10, 1983
BILE ESCULIN AZIDE AGAR
K830080 · JSJ
bioMerieux, Inc.
Immunology · 30d
Cleared Feb 10, 1983
BIGGY AGAR
K830082 · JSI
bioMerieux, Inc.
Immunology · 30d
Cleared Feb 09, 1983
MUELLER HINTON W/50% SHEEP BLOOD
K830059 · JTC
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MUELLER HINTON
K830060 · JTZ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
THAYER-MARTIN, MODIFIED
K830061 · JTY
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MARTIN-LEWIS AGAR
K830062 · JTY
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
CONTACT PLATE LECITHIN & POLYSORBATE 80
K830063 · JSG
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
XLD AGAR
K830064 · JSI
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
SABOURAND DEXTROSE AGAR
K830066 · JSJ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
PHENYLETHANOL AGAR W/50% SHEEP BLOOD
K830067 · JSJ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
NUTRIENT AGAR
K830068 · JSG
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MYCOBIOTIC AGAR
K830069 · JSJ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MANNITOL SALT AGAR
K830070 · JSI
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MACCONKEY AGAR
K830071 · JSI
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
HEKTOEN ENTERIC AGAR
K830072 · JSI
bioMerieux, Inc.
Immunology · 29d