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
2161–2184 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 19, 1991
QUANTA LITE(TM) ACA
K911680 · MID
Inova Diagnostics, Inc.
Immunology · 218d
Cleared Nov 19, 1991
ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK
K914226 · JZB
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 60d
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