Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
1945–1968 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 23, 1993
SYNELISA TG ANTIBODIES/TPO ANTIBODIES
K933123 · JZS
Elias U.S.A., Inc.
Immunology · 56d
Cleared Aug 16, 1993
IMMULITE TOTAL IGE
K931703 · JHR
Diagnostic Products Corp.
Immunology · 132d
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