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
2809–2832 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 06, 1985
ANTI-CYTOMEGALOVIRUS KIT
K842661 · GQI
Amico Lab, Inc.
Immunology · 514d
Cleared Dec 06, 1985
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
K842663 · GQO
Amico Lab, Inc.
Immunology · 514d
Cleared Nov 27, 1985
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
K850683 · DEB
Kent Laboratories, Inc.
Immunology · 279d
Cleared Nov 25, 1985
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · DDB
Kent Laboratories, Inc.
Immunology · 277d
Cleared Nov 25, 1985
CANTROL SPINAL FLUID CONTROL
K854190 · DFI
Canyon Diagnostics, Inc.
Immunology · 41d
Cleared Nov 25, 1985
DIESSE CRP TEST KIT
K854221 · DCK
Marvic Interpharma, Inc.
Immunology · 38d
Cleared Nov 18, 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K853969 · DHB
Pharmacia, Inc.
Immunology · 53d
Cleared Nov 12, 1985
MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
K852932 · GRF
Microbix Biosystems, Inc.
Immunology · 126d
Cleared Nov 07, 1985
ALLERG-E IGE ENZYME IMMUNOASSAY KIT
K853607 · DGO
Dexall Biomedical Labs, Inc.
Immunology · 71d
Cleared Nov 05, 1985
ENZYGNOST ANTIHERPES SIMPLEX VIRUS
K841245 · GQO
Behring Diagnostics, Inc.
Immunology · 592d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN PREALBUMIN
K850686 · JZJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN B
K850690 · MSJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
K850691 · MSJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Oct 25, 1985
LACTOPLATE
K852737 · DEG
Mackeen Consultants, Ltd.
Immunology · 120d
Cleared Oct 21, 1985
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · DEH
Kallestad Laboratories, Inc.
Immunology · 98d
Cleared Oct 16, 1985
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY
K850895 · DHB
Ventrex Laboratories, Inc.
Immunology · 226d
Cleared Oct 16, 1985
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
K853144 · KTN
Preco, Inc.
Immunology · 79d
Cleared Sep 19, 1985
ALLERCOAT ALLERGEN DISCS
K852794 · DHB
Kallestad Laboratories, Inc.
Immunology · 80d
Cleared Sep 19, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K853456 · DHB
Pharmacia, Inc.
Immunology · 34d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN G REAGENT
K853465 · DEW
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD C3 COMPLEMENT REAGENT
K853466 · CZW
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN A REAGENT
K853467 · CZP
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD C4 COMPLEMENT REAGENT
K853468 · DBI
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN M REAGENT
K853469 · DFT
Gilford
Immunology · 28d