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
1633–1656 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 05, 1996
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
K951965 · DEH
Dako Corp.
Immunology · 435d
Cleared Jul 02, 1996
CHEMMATE(TM) CD43
K950148 · DEH
Biotek Solutions, Inc.
Immunology · 532d
Cleared Jun 26, 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · DHR
Randox Laboratories, Ltd.
Immunology · 93d
Cleared Jun 20, 1996
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · JZO
Immco Diagnostics, Inc.
Immunology · 147d
Cleared Jun 20, 1996
THYROGLOBULIN ANTIBODY ELISA
K960370 · JZO
Immco Diagnostics, Inc.
Immunology · 147d
Cleared Jun 14, 1996
COMPLEMENT CONTROL
K960874 · JJX
Wako Chemicals USA, Inc.
Immunology · 102d
Cleared Jun 04, 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · DHR
Bio-Rad
Immunology · 85d
Cleared May 30, 1996
VENTANNA ANTI-CD3 PRIMARY ANTIBODY
K941505 · DEH
Ventana Medical Systems, Inc.
Immunology · 793d
Cleared May 30, 1996
DIASTAT ANTI-CARDIOLIPIN KIT
K955303 · MID
Shield Diagnostics, Ltd.
Immunology · 192d
Cleared May 23, 1996
RIBOSOMAL P EIA TEST SYSTEM
K950169 · MQA
Hogan & Hartson
Immunology · 492d
Cleared May 23, 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
K955449 · MID
American Laboratory Products Co., Ltd.
Immunology · 176d
Cleared May 08, 1996
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830 · LKP
Orgentec
Immunology · 201d
Cleared May 08, 1996
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831 · LKO
Orgentec
Immunology · 201d
Cleared May 08, 1996
RF IGM ELISA TEST SYSTEM
K961277 · DHR
Zeus Scientific, Inc.
Immunology · 35d
Cleared Apr 23, 1996
RIT LIVER, KIDNEY, STOMACH IFA KIT
K955431 · DBL
The Binding Site, Ltd.
Immunology · 147d
Cleared Apr 19, 1996
RELSIA SCL-70 ANTIBODY TEST SYSTEM
K955602 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
K955603 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA SM/RNP ANTIBODY TEST SYSTEM
K955604 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA JO-1 ANTIBODY TEST SYSTEM
K955605 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
CRP-LATEX SEIKEN XR REAGENT SYSTEM
K960702 · DCK
Globe Management Support, Inc.
Immunology · 59d
Cleared Apr 19, 1996
RF-LATEX SEIKEN REAGENT SYSTEM
K960703 · DHR
Globe Management Support, Inc.
Immunology · 59d
Cleared Apr 18, 1996
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
K954814 · LJM
Orgentec
Immunology · 182d
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
K954815 · LJM
Orgentec
Immunology · 182d
Cleared Apr 18, 1996
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
K954829 · LJM
Orgentec
Immunology · 181d