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
1273–1296 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Nov 04, 1998
C4
K983356 · DBI
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
IGA
K983359 · CZP
Abbott Laboratories
Immunology · 41d