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
2545–2568 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 21, 1988
MULTICHEM (R) MAGNESIUM REAGENT
K874595 · JGJ
Simmler, Inc.
Immunology · 73d
Cleared Jan 21, 1988
V-TREND BETA-HCG TEST
K874638 · JHJ
Texas Immunology, Inc.
Immunology · 70d
Cleared Jan 11, 1988
IVT SOUTHEAST ALLERGY SCREEN
K874168 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 11, 1988
IVT NORTHEAST ALLERGY SCREEN
K874169 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 05, 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · JHI
Diagnostic Products Corp.
Immunology · 95d
Cleared Dec 30, 1987
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
K874446 · DHB
3M Company
Immunology · 63d
Cleared Dec 29, 1987
RF DIPSTICK TEST KIT
K874151 · DHR
Lipogen, Inc.
Immunology · 77d
Cleared Dec 18, 1987
NDNA ANTIBODY TEST KIT
K874191 · LRM
Lipogen, Inc.
Immunology · 65d
Cleared Dec 18, 1987
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281 · DHB
Medix Biotech, Inc.
Immunology · 59d
Cleared Dec 14, 1987
DIFFERENTIAL I.M. SCREENING TEST
K873297 · KTN
Sclavo, Inc.
Immunology · 118d
Cleared Dec 14, 1987
I.M.N. LATEX
K874678 · KTN
Biokit USA, Inc.
Immunology · 31d
Cleared Dec 02, 1987
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
K874572 · DBF
Nichols Institute Diagnostics
Immunology · 27d
Cleared Nov 27, 1987
REUMA TEST
K873782 · DHR
Sclavo, Inc.
Immunology · 72d
Cleared Nov 25, 1987
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
K873708 · LLL
Whittaker Bioproducts, Inc.
Immunology · 71d
Cleared Nov 25, 1987
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031 · DBF
Diagnostic Products Corp.
Immunology · 54d
Cleared Nov 25, 1987
CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
K874379 · CZY
Cytotech, Inc.
Immunology · 30d
Cleared Nov 25, 1987
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
K874406 · DGC
Medix Biotech, Inc.
Immunology · 28d
Cleared Nov 25, 1987
LIVE OAK ALLERGEN DISC
K874440 · DHB
Incstar Corp.
Immunology · 28d
Cleared Nov 04, 1987
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
K873064 · DHR
Amtec Diagnostics International, Inc.
Immunology · 91d
Cleared Nov 04, 1987
IMMUSTRIP(TM) SM ELISA TEST SYSTEM
K873741 · LKP
Immunomedics, Inc.
Immunology · 49d
Cleared Nov 04, 1987
GIANT RAGWEED ALLERGEN DISC
K873969 · DHB
Incstar Corp.
Immunology · 36d
Cleared Nov 04, 1987
TOTAL IGE FAST (TM) TEST PACKAGE
K873998 · DHB
3M Company
Immunology · 34d
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · LKJ
Sigma Diagnostics, Inc.
Immunology · 26d
Cleared Nov 04, 1987
JOHNSON GRASS ALLERGEN DISC
K874150 · DHB
Incstar Corp.
Immunology · 22d