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
2305–2328 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 08, 1989
VENTREZYME VAST SPECIFIC IGE ASSAY
K896694 · DHB
Ventrex Laboratories, Inc.
Immunology · 10d
Cleared Dec 05, 1989
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
K896347 · LJM
General Biometrics, Inc.
Immunology · 32d
Cleared Dec 04, 1989
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585 · DBF
Medix Biotech, Inc.
Immunology · 13d
Cleared Dec 04, 1989
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K896592 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 13d
Cleared Dec 01, 1989
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483 · DEB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 18d
Cleared Nov 20, 1989
NOVA GEL(TM) T SM/RNP
K896459 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T SS-A/SS-B
K896460 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T SCL-70
K896461 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T JO-1
K896462 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 13, 1989
ABBOTT IMX IGE
K895914 · DGC
Abbott Laboratories
Immunology · 34d
Cleared Nov 08, 1989
HUMAN (IGG) SUBCLASS (EIA) KIT
K895600 · DAS
The Binding Site, Ltd.
Immunology · 51d
Cleared Nov 08, 1989
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
K896271 · DHR
Biokit USA, Inc.
Immunology · 9d
Cleared Nov 08, 1989
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
K896272 · DCN
Biokit USA, Inc.
Immunology · 9d
Cleared Nov 06, 1989
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES
K895996 · LKP
Lipogen, Inc.
Immunology · 24d
Cleared Nov 06, 1989
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
K895997 · LKO
Lipogen, Inc.
Immunology · 24d
Cleared Nov 06, 1989
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Oct 31, 1989
LEECO PREVIEW(R) EBV (EIA)
K895765 · KTN
Leeco Diagnostics, Inc.
Immunology · 35d
Cleared Oct 31, 1989
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · KTN
Gull Laboratories, Inc.
Immunology · 26d
Cleared Oct 27, 1989
RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES
K895995 · LJM
Lipogen, Inc.
Immunology · 14d
Cleared Oct 24, 1989
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
K895994 · LJM
Lipogen, Inc.
Immunology · 11d
Cleared Oct 17, 1989
ANTI-RNP AND ANTI-SM ANTIBODY TEST
K895338 · LKO
Immco Diagnostics, Inc.
Immunology · 47d
Cleared Oct 17, 1989
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
K895808 · DCF
Technicon Instruments Corp.
Immunology · 15d
Cleared Oct 17, 1989
LAN.0800Q/2800Q
K895872 · DBF
Amersham Corp.
Immunology · 13d
Cleared Oct 06, 1989
ORTHO *APO A-1 ELISA TEST SYSTEM
K895160 · DEL
Medical Marketing Consultants, Inc.
Immunology · 44d