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
2953–2976 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 15, 1984
STREPTEX ZL01
K842828 · JTO
Wellcome Diagnostics
Immunology · 26d
Cleared Aug 03, 1984
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328 · DEH
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 51d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY KIT
K842326 · DFH
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · DFT
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · DEW
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGA 2720-21
K842330 · CZP
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
GENETIC SYS LEGIONELLA IMMUNOFLURORES
K842683 · LHL
Genetic Systems Corp.
Immunology · 23d
Cleared Jul 11, 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · DEH
Kallestad Laboratories, Inc.
Immunology · 68d
Cleared Jul 11, 1984
FIAX TRANSFERRIN TEST KIT
K842071 · DDI
Intl. Diagnostic Technology
Immunology · 49d
Cleared Jul 11, 1984
LEAP LE TEST KIT
K842484 · LKJ
Cooper Biomedical, Inc.
Immunology · 16d
Cleared Jul 02, 1984
GENERAL DIAGNOSTICS PLATELET ANTIBODY
K841465 · LLG
General Diagnostics
Immunology · 84d
Cleared Jul 02, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457 · DHB
Pharmacia, Inc.
Immunology · 10d
Cleared Jun 26, 1984
MELOY AUTOANTIBODY TEST SYS
K842247 · DBM
Meloy Laboratories, Inc.
Immunology · 20d
Cleared Jun 22, 1984
GMP CIQ ELISA TEST KIT
K833275 · DAK
Gamma Medical Products, Inc.
Immunology · 275d
Cleared Jun 22, 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · DHN
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Jun 22, 1984
OPTIMATE IGM TEST
K841814 · DFT
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1984
OPTIMATE IGG TEST
K841816 · DEW
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1984
ADP ANA IFA TEST
K842183 · DHN
Apple Diagnostic Products
Immunology · 21d
Cleared Jun 14, 1984
ALLO-TYPE HUMAN IMMUNOGLOBULIN-
K841114 · DGX
Genetic Testing Institute
Immunology · 91d
Cleared Jun 13, 1984
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · DAK
Ortho Diagnostic Systems, Inc.
Immunology · 240d
Cleared Jun 13, 1984
IMMU-TEC
K841862 · DCK
Medilab Corp.
Immunology · 40d
Cleared Jun 13, 1984
MONO-TEC
K841863 · KTN
Medilab Corp.
Immunology · 40d
Cleared Jun 11, 1984
MODIFICATION TO ACS CORONARY GUIDING
K841992 · DAO
Advanced Cardiovascular Systems, Inc.
Immunology · 47d
Cleared Jun 07, 1984
MAST LUMINESCENT ALLERGY SYS
K841642 · DGC
Mast Immunosystems
Immunology · 48d