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
2857–2880 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 27, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263 · DHB
Pharmacia, Inc.
Immunology · 34d
Cleared Jun 21, 1985
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K851403 · JQW
Ventrex Laboratories, Inc.
Immunology · 73d
Cleared Jun 21, 1985
LASER PREALBUMIN TEST
K851912 · JZJ
Behring Diagnostics, Inc.
Immunology · 51d
Cleared Jun 21, 1985
SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
K852033 · DHN
Meloy Laboratories, Inc.
Immunology · 43d
Cleared Jun 17, 1985
RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
K851285 · DCF
Cooper Biomedical, Inc.
Immunology · 77d
Cleared Jun 13, 1985
ROTAVIRUS ENZYME IMMUNOASSAY
K843367 · LIQ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 289d
Cleared Jun 11, 1985
RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
K851284 · CZP
Cooper Biomedical, Inc.
Immunology · 71d
Cleared Jun 11, 1985
SMS, SCREEN MACHINE SYSTEM
K852240 · JZT
Pandex Laboratories, Inc.
Immunology · 19d
Cleared Jun 05, 1985
RADIAL IMMUNODIFFUSION PLATES C3 & C4
K851286 · CZW
Cooper Biomedical, Inc.
Immunology · 65d
Cleared Jun 05, 1985
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · DHR
Behring Diagnostics, Inc.
Immunology · 50d
Cleared Jun 05, 1985
APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
K851649 · DER
Photec Diagnostics, Inc.
Immunology · 44d
Cleared Jun 05, 1985
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K851842 · DCK
Atlantic Antibodies
Immunology · 40d
Cleared Jun 04, 1985
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
K844762 · GTJ
Wellcome Diagnostics
Immunology · 179d
Cleared May 28, 1985
ALLERGENETICS IGE FAST TEST
K851512 · DHB
Allergenetics
Immunology · 43d
Cleared May 24, 1985
RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI
K851282 · DEB
Cooper Biomedical, Inc.
Immunology · 53d
Cleared May 24, 1985
RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
K851287 · DDG
Cooper Biomedical, Inc.
Immunology · 53d
Cleared May 23, 1985
RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN
K851283 · DDB
Cooper Biomedical, Inc.
Immunology · 52d
Cleared May 20, 1985
ABBOTT HSV EIA
K843622 · LGC
Abbott Laboratories
Immunology · 248d
Cleared May 15, 1985
ANTINUCLEAR ANTIBODY TEST KIT
K851369 · DHN
Modern Diagnostics, Inc.
Immunology · 40d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
K850410 · DDX
Warner-Lambert Co.
Immunology · 93d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
K850411 · LGP
Warner-Lambert Co.
Immunology · 93d
Cleared Apr 29, 1985
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
K851202 · DAK
Gilford
Immunology · 34d
Cleared Apr 29, 1985
MUELLER HINTON SENSITIVITY PLATE
K851518 · JTZ
Culture Kits, Inc.
Immunology · 14d
Cleared Apr 25, 1985
IGM RHEUMATOID FACTOR TEST KIT
K851099 · DHR
Breit Laboratories, Inc.
Immunology · 37d