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
2161–2184 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 07, 1991
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
K913131 · JZG
The Binding Site, Ltd.
Immunology · 114d
Cleared Nov 07, 1991
3M ANTI-DSDNA FAST TEST
K913653 · LRM
3M Diagnostic Systems, Inc.
Immunology · 83d
Cleared Nov 05, 1991
ANTI-DSDNA ANTIBODY TEST
K913041 · LLL
Helix Diagnostics, Inc.
Immunology · 119d
Cleared Oct 28, 1991
C1 RID KIT
K914388 · DAK
The Binding Site, Ltd.
Immunology · 27d
Cleared Oct 02, 1991
FASTTECH SYSTEM II
K913892 · DHB
3M Diagnostic Systems, Inc.
Immunology · 33d
Cleared Oct 02, 1991
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
K914069 · MSJ
Medical Analysis Systems, Inc.
Immunology · 21d
Cleared Sep 23, 1991
ANTI-JO-1 MICROASSAY
K911679 · LLL
Diamedix Corp.
Immunology · 161d
Cleared Sep 23, 1991
ANTI-DNA MICROASSAY
K912020 · LRM
Diamedix Corp.
Immunology · 139d
Cleared Sep 23, 1991
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
K912749 · MSJ
Medical Analysis Systems, Inc.
Immunology · 94d
Cleared Sep 10, 1991
ANTI-GBM ANTIBODIES QUANTITATIVE KIT
K904181 · DBL
Biochemical Diagnostic, Inc.
Immunology · 364d
Cleared Aug 13, 1991
DSL BETA 2 MICROGLOBULIN (DSL 6100)
K912173 · JZG
Diagnostic Systems Laboratories, Inc.
Immunology · 89d
Cleared Aug 12, 1991
OPUS(R) ROZO
K911834 · LGD
Pb Diagnostic Systems, Inc.
Immunology · 109d
Cleared Aug 12, 1991
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA
K911903 · DHB
Pharmacia, Inc.
Immunology · 105d
Cleared Jul 31, 1991
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K912582 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 49d
Cleared Jul 30, 1991
DISTAT ANTI-SCL-70 KIT
K912291 · LKJ
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Jul 30, 1991
DIASTAT ANTI-JO-1 KIT
K912292 · DHN
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Jul 25, 1991
KALLESTEAD TOTAL IGE MICROPLATE KIT
K912800 · DGC
Bio-Rad Laboratories, Inc.
Immunology · 30d
Cleared Jul 24, 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · JZG
Diagnostic Products Corp.
Immunology · 19d
Cleared Jul 22, 1991
HUMAN C-REACTIVE PROTEIN RID KIT
K905633 · DCK
The Binding Site, Ltd.
Immunology · 220d
Cleared Jun 21, 1991
BIOCLONE'S ELEGANCE IGE ELISA KIT
K910419 · DGC
Bioclone Australia Pty , Ltd.
Immunology · 142d
Cleared Jun 12, 1991
ELISA COMBI-KIT HUMAN IGG SUBCLASSES
K911610 · DEW
Janssen Research Foundation
Immunology · 79d
Cleared May 31, 1991
RHEUMAGEN RF T-CONTROL
K904310 · DHR
Biokit USA, Inc.
Immunology · 254d
Cleared May 15, 1991
NATIVE PROTHROMBIN ANTIGEN EIA
K910617 · DDF
Organon Teknika Corp.
Immunology · 92d
Cleared May 09, 1991
RAICHEM SPIA C4 REAGENT
K911899 · DBI
Reagents Applications, Inc.
Immunology · 13d