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
2305–2328 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 02, 1990
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
K897025 · DHN
Zeus Scientific, Inc.
Immunology · 14d
Cleared Dec 18, 1989
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K896852 · DHB
Ventrex Laboratories, Inc.
Immunology · 13d
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