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
2713–2736 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 03, 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBE
K863036 · DHB
Pharmacia, Inc.
Immunology · 52d
Cleared Oct 01, 1986
IMMUNO BIOTECH MUGWART ALLERGEN DISC
K863123 · DHB
Immuno Nuclear Corp.
Immunology · 48d
Cleared Oct 01, 1986
QUANTIMUNE(R) FERRITIN IRMA
K863487 · DBF
Bio-Rad
Immunology · 22d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST
K863328 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR
K863329 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Sep 18, 1986
MICROALBUMINURIA ASSAY
K862671 · DCF
Orion Corp.
Immunology · 66d
Cleared Sep 17, 1986
PRECIMAT (R) IGA, G, M
K863352 · CZP
Boehringer Mannheim Corp.
Immunology · 19d
Cleared Sep 17, 1986
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA
K863355 · DHB
Pharmacia, Inc.
Immunology · 19d
Cleared Sep 16, 1986
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY
K862901 · DHB
Ventrex Laboratories, Inc.
Immunology · 47d
Cleared Sep 15, 1986
MEADOW FESCUE ALLERGEN DISC
K863098 · DHB
Immuno Nuclear Corp.
Immunology · 33d
Cleared Sep 08, 1986
TINA-QUANT(R) IGM
K862762 · DFT
Boehringer Mannheim Corp.
Immunology · 48d
Cleared Sep 08, 1986
125-I TSH RECEPTOR ANTIBODY KIT
K863006 · JZO
Cronus
Immunology · 31d
Cleared Sep 04, 1986
CYTOTECH CIC ENZYME IMMUNOASSAY
K862649 · DAK
Cytotech, Inc.
Immunology · 55d
Cleared Sep 04, 1986
TINA-QUANT(R) IGA
K862763 · CZP
Boehringer Mannheim Corp.
Immunology · 44d
Cleared Sep 03, 1986
TINA-QUANT(R) IGG
K862764 · DEW
Boehringer Mannheim Corp.
Immunology · 43d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
K854944 · DAH
Abbott Laboratories
Immunology · 260d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · CZP
Abbott Laboratories
Immunology · 253d
Cleared Aug 27, 1986
PHASE II FERRITIN RADIOIMMUNOASSAY KIT
K862960 · DBF
Medical & Scientific Designs, Inc.
Immunology · 22d
Cleared Aug 25, 1986
DAKO ITA SYSTEM
K861059 · DEW
Dako Corp.
Immunology · 159d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN A (IGA)
K862183 · CZP
Dako Corp.
Immunology · 71d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN M (IGM)
K862184 · DAH
Dako Corp.
Immunology · 71d
Cleared Aug 19, 1986
MAPLE ALLERGEN DISC
K862266 · DHB
Immuno Nuclear Corp.
Immunology · 67d
Cleared Aug 19, 1986
SERATEST ENA [SS-B] KIT
K862700 · LLL
Hemagen Diagnostics, Inc.
Immunology · 35d
Cleared Aug 15, 1986
RUSSIAN THISTLE ALLERGEN DISC
K862176 · DHB
Immuno Nuclear Corp.
Immunology · 67d