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
2137–2160 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 17, 1992
IL TEST(TM) TRANSFERRIN (TRF)
K914993 · DDG
Instrumentation Laboratory CO
Immunology · 71d
Cleared Jan 17, 1992
COMPLEMENT C1 INACTIVATOR KIT
K915431 · DBA
The Binding Site, Ltd.
Immunology · 46d
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