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
1945–1968 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 16, 1993
APO A-1 CHEMILUMINESCENCE ASSAY
K931777 · MSJ
Nichols Institute
Immunology · 129d
Cleared Aug 10, 1993
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
K930987 · KTL
The Binding Site, Ltd.
Immunology · 166d
Cleared Aug 10, 1993
ANA PROFILE I
K932424 · LJM
Apotex Scientific, Inc.
Immunology · 83d
Cleared Aug 09, 1993
VENTANA RED DETECTION KIT
K932386 · DEY
Ventana Medical Systems, Inc.
Immunology · 84d
Cleared Aug 09, 1993
ACCUTEX IM LATEX TEST
K932551 · KTN
J.S. Medical Assoc.
Immunology · 75d
Cleared Aug 06, 1993
PSA ANTIBODY KIT
K932326 · DEH
Ventana Medical Systems, Inc.
Immunology · 100d
Cleared Aug 05, 1993
DADE(R) TUMOR MARKER CONTROL
K924919 · JJY
Baxter Diagnostics, Inc.
Immunology · 310d
Cleared Aug 05, 1993
COBAS(R) CORE IGE TOTAL EIA
K930890 · DGC
Roche Diagnostic Systems, Inc.
Immunology · 164d
Cleared Aug 05, 1993
VISTA FERRITIN ASSAY
K931576 · DBF
Syva Co.
Immunology · 128d
Cleared Aug 05, 1993
ANTI-SS-B/LA ANTIBODY TEST
K932419 · LLL
Helix Diagnostics, Inc.
Immunology · 79d
Cleared Aug 05, 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
K933180 · DGC
Inova Diagnostics, Inc.
Immunology · 36d
Cleared Aug 03, 1993
SYNELISA PARIETAL CELL ANTIBODIES
K930422 · DBJ
Elias U.S.A., Inc.
Immunology · 189d
Cleared Jul 28, 1993
TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3
K931366 · JJY
Medical Analysis Systems, Inc.
Immunology · 133d
Cleared Jul 16, 1993
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
K931495 · LLL
Helix Diagnostics, Inc.
Immunology · 113d
Cleared Jul 16, 1993
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
K931806 · CZP
The Binding Site, Ltd.
Immunology · 95d
Cleared Jul 16, 1993
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
K932373 · MID
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Jul 06, 1993
LACTOCARD
K931901 · DEG
Touch Scientific, Inc.
Immunology · 78d
Cleared Jul 06, 1993
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
K932225 · MID
Immuno Concepts, Inc.
Immunology · 60d
Cleared Jun 28, 1993
MULTITROL IMMUNOLOGY CONTROL
K923663 · JJY
Behring Diagnostics, Inc.
Immunology · 341d
Cleared Jun 11, 1993
SYNELISA RO ABS / LA ABS
K930209 · LJM
Elias U.S.A., Inc.
Immunology · 147d
Cleared Jun 09, 1993
ANTI-ENDOMYSIAL ANTIBODY TEST
K912551 · DBL
Immco Diagnostics, Inc.
Immunology · 729d
Cleared Jun 09, 1993
ACCESS(R) TOTAL IGE ASSAY
K930984 · DGC
Bio-Rad Laboratories, Inc.
Immunology · 104d
Cleared May 20, 1993
HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
K926114 · DHN
Tissue Culture Biotec, Inc.
Immunology · 168d
Cleared May 20, 1993
VIDAS TOTAL IGE (IGE) ASSAY
K931224 · DGP
Biomerieux Vitek, Inc.
Immunology · 71d