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
1273–1296 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 04, 1998
HUMAN IGA SUBCLASS BNII COMBI KIT
K981912 · CFN
The Binding Site, Ltd.
Immunology · 186d
Cleared Nov 30, 1998
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
K982898 · MOB
Immco Diagnostics, Inc.
Immunology · 105d
Cleared Nov 30, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN...
K984034 · MOB
Zeus Scientific, Inc.
Immunology · 18d
Cleared Nov 25, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
K983895 · JZG
Beckman Coulter, Inc.
Immunology · 22d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN...
K983376 · LLL
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN...
K983378 · LJM
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
IS-ANTI-MPO IGG ELISA TEST SYSTEM
K983390 · MOB
Columbia Bioscience, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST...
K983418 · DHR
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK...
K983420 · LKP
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED...
K983422 · LRM
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME...
K983423 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME...
K983425 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME...
K983426 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME...
K983464 · LLL
Zeus Scientific, Inc.
Immunology · 48d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME...
K983465 · LKO
Zeus Scientific, Inc.
Immunology · 48d
Cleared Nov 18, 1998
IS-ANTI-PR3 IGG ELISA TEST SYSTEM
K983740 · MOB
Columbia Bioscience, Inc.
Immunology · 27d
Cleared Nov 12, 1998
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · DGC
Boehringer Mannheim Corp.
Immunology · 62d
Cleared Nov 09, 1998
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
K981871 · DCK
Diagnostic Systems Laboratories, Inc.
Immunology · 165d
Cleared Nov 04, 1998
SPIFE URINE IFE
K982639 · DAO
Helena Laboratories
Immunology · 98d
Cleared Nov 04, 1998
QUANTA LITE RF IGG ELISA
K983083 · DHR
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Nov 04, 1998
QUANTA LITE RF IGA ELISA
K983084 · DHR
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Nov 04, 1998
IGM
K983132 · DFT
Abbott Laboratories
Immunology · 57d
Cleared Nov 04, 1998
TRF
K983167 · DDG
Abbott Laboratories
Immunology · 55d
Cleared Nov 04, 1998
IGG
K983221 · DEW
Abbott Laboratories
Immunology · 51d