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
2137–2160 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 15, 1992
TIA CRP TEST KIT
K914155 · DCK
Crestat Diagnostics, Inc.
Immunology · 121d
Cleared Jan 15, 1992
ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
K914853 · LJM
Reads Medical Products, Inc.
Immunology · 79d
Cleared Dec 20, 1991
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
K913668 · DDB
The Binding Site, Ltd.
Immunology · 123d
Cleared Dec 20, 1991
PREALBUMIN IMMUNOLOGICAL NL TEST KIT
K913672 · JZJ
The Binding Site, Ltd.
Immunology · 123d
Cleared Dec 20, 1991
ALPHA-2 MACROGLOBULIN TEST RID KIT
K914389 · DEB
The Binding Site, Ltd.
Immunology · 80d
Cleared Dec 20, 1991
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K915058 · LLL
Hemagen Diagnostics, Inc.
Immunology · 42d
Cleared Dec 20, 1991
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
K915234 · LLL
Hemagen Diagnostics, Inc.
Immunology · 28d
Cleared Dec 18, 1991
READS(R) IGA ANTI-CARDIOLIPIN TEST KIT
K914405 · MID
Reads Medical Products, Inc.
Immunology · 77d
Cleared Dec 10, 1991
ALBUMIN TEST RID KIT
K914391 · DCF
The Binding Site, Ltd.
Immunology · 70d
Cleared Dec 09, 1991
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661 · MID
Immuno Concepts, Inc.
Immunology · 241d
Cleared Dec 09, 1991
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT
K913666 · DEM
The Binding Site, Ltd.
Immunology · 112d
Cleared Dec 09, 1991
HAPTOGLOBIN IMMUNOLOGICAL TEST KIT
K913670 · DAB
The Binding Site, Ltd.
Immunology · 112d
Cleared Dec 09, 1991
TRANSFERRIN RID KIT
K914390 · DDG
The Binding Site, Ltd.
Immunology · 69d
Cleared Dec 09, 1991
IMMUNOWELL DSDNA ANTIBODY TEST
K914801 · DHC
General Biometrics, Inc.
Immunology · 46d
Cleared Dec 09, 1991
CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE
K914850 · DHB
Mast Immunosystems
Immunology · 42d
Cleared Dec 02, 1991
HUMAN IGD IMMUNOLOGICAL NL TEST KIT
K913671 · CZJ
The Binding Site, Ltd.
Immunology · 105d
Cleared Nov 29, 1991
ABBOTT MATRIX AERO PLUS SYSTEM
K913150 · DHB
Abbott Laboratories
Immunology · 136d
Cleared Nov 29, 1991
IL TEST(TM DIGOXIN
K914151 · KXT
Instrumentation Laboratory CO
Immunology · 74d
Cleared Nov 27, 1991
3M ANTI-CARDIOLIPIN FAST(TM) TEST
K913054 · MID
3M Diagnostic Systems, Inc.
Immunology · 141d
Cleared Nov 22, 1991
ALLERGY INFORMATION MANAGER
K912294 · DHB
Diagnostic Products Corp.
Immunology · 186d
Cleared Nov 22, 1991
3M IGE SINGLE POINT FAST TEST
K913212 · DHB
Whittaker Bioproducts, Inc.
Immunology · 126d
Cleared Nov 22, 1991
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225 · JZG
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 63d
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