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
3025–3048 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 30, 1984
TRANSFERRIN, ANTIGEN, ANTIBODY, CONTROL
K834603
Technicon Instruments Corp.
Immunology · 122d
Cleared Jan 24, 1984
C3 ANTISERUM CONTROL
K834604 · CZW
Technicon Instruments Corp.
Immunology · 116d
Cleared Jan 24, 1984
C4 ANTIGEN ANTIBODY CONTROL
K834605 · DBI
Technicon Instruments Corp.
Immunology · 116d
Cleared Jan 20, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
K834140 · KTL
Intl. Diagnostic Technology
Immunology · 51d
Cleared Jan 10, 1984
WELLCOGEN N. MENINGITIDIS A,C,Y W135
K833063 · GTJ
Wellcome Diagnostics
Immunology · 123d
Cleared Jan 10, 1984
WELLCOGEN H. INFLUENZAL ZL21
K833077 · GRD
Wellcome Diagnostics
Immunology · 123d
Cleared Jan 04, 1984
MAST INHALANT PROFILE
K833885 · DHB
Mast Immunosystems
Immunology · 56d
Cleared Jan 04, 1984
MAST TOTAL IGE
K833969 · DGC
Mast Immunosystems
Immunology · 49d
Cleared Jan 04, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
K833984 · KTL
Intl. Diagnostic Technology
Immunology · 48d
Cleared Jan 03, 1984
NORMAL GOAT SERUM
K833318 · DHX
Biosan Laboratories, Inc.
Immunology · 99d
Cleared Dec 27, 1983
MUMPS COMPLEMENT FIXATION & HEMAGGLU
K832873 · GRC
Hazleton Dutchland, Inc.
Immunology · 124d
Cleared Dec 27, 1983
EBV-VCA-IGM IFA TEST SYSTEM
K833014 · LJN
Zeus Scientific, Inc.
Immunology · 112d
Cleared Dec 27, 1983
LEAP STREP TEST KIT
K833738 · GTP
Cooper Biomedical, Inc.
Immunology · 63d
Cleared Dec 08, 1983
VENTREZYME EIA CONTROLS-IMMUNOASSAY
K833423 · JJY
Ventrex Laboratories, Inc.
Immunology · 66d
Cleared Nov 28, 1983
CORDIA HS
K832875 · GQN
Cordis Corp.
Immunology · 94d
Cleared Nov 28, 1983
FPC FECAL PARASITE CONCENTRATOR
K833469 · LKS
Evergreen Scientific, Inc.
Immunology · 53d
Cleared Nov 25, 1983
POLYSTYRENE MICROTITER WELL IMMUNOSOR
K832345 · DGC
Diagnostic Reagent Tech.
Immunology · 130d
Cleared Nov 21, 1983
POLYSTYRENE MICROTITER PLATE IMMUNO-
K832344 · DHB
Diagnostic Reagent Tech.
Immunology · 131d
Cleared Nov 21, 1983
DIACROM *PLG
K832591 · DDX
Wellcome Diagnostics
Immunology · 111d
Cleared Nov 21, 1983
COLOSCREEN V.P.I.
K832864 · KHE
Helena Laboratories
Immunology · 90d
Cleared Nov 21, 1983
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119 · DHN
Atlantic Antibodies
Immunology · 69d
Cleared Nov 21, 1983
TAGO DIFFU-GEN-APOLIPOPROTEIN B-100
K833129 · MSJ
Tago, Inc.
Immunology · 69d
Cleared Nov 21, 1983
ENZYME ANA TEST SYSTEM
K833148 · LJM
Immuno Concepts, Inc.
Immunology · 67d
Cleared Nov 21, 1983
VENTRESCREEN BETA-HCG ENZYME IMMUNO
K833909 · ETD
Vxr, Inc.
Immunology · 7d