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

1921–1944 of 3,794

Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology

Cleared Dec 27, 1993

IMMUNOCARD MONO

Meridian Diagnostics, Inc.

Immunology · 314d

Cleared Dec 21, 1993

QUANTA LITE(TM) HISTONE ELISA

Inova Diagnostics, Inc.

Immunology · 124d

Cleared Dec 15, 1993

AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM

Zeus Scientific, Inc.

Immunology · 162d

Cleared Dec 08, 1993

ELIAS CARDIOLIPIN IGM ANTIBODIES

Elias U.S.A., Inc.

Immunology · 149d

Cleared Dec 08, 1993

ELIAS CARDIOLIPIN IGG ANTIBODIES

Elias U.S.A., Inc.

Immunology · 149d

Cleared Dec 03, 1993

SYNELISA ANA PROFILE

Elias U.S.A., Inc.

Immunology · 211d

Cleared Dec 03, 1993

LACTOFERRIN MICROASSAY SYSTEM

Touch Scientific, Inc.

Immunology · 80d

Cleared Nov 15, 1993

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

Shield Diagnostics, Ltd.

Immunology · 154d

Cleared Nov 03, 1993

BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY

Boehringer Mannheim Corp.

Immunology · 100d

Cleared Oct 15, 1993

DIASTAT ANTI-CENTROMERE KIT

Shield Diagnostics, Ltd.

Immunology · 123d

Cleared Oct 12, 1993

ACCESS FOLATE ASSAY

Beckman Coulter, Inc.

Immunology · 120d

Cleared Oct 07, 1993

BECKMAN TRANSFERRIN KIT

Beckman Instruments, Inc.

Immunology · 293d

Cleared Sep 24, 1993

SYNELISA CENP-B ANTIBODIES

Elias U.S.A., Inc.

Immunology · 196d

Cleared Sep 24, 1993

IMMULITE BETA-2-MICROGLOBULIN

Diagnostic Products Corp.

Immunology · 171d

Cleared Sep 24, 1993

ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN

Helix Diagnostics, Inc.

Immunology · 106d

Cleared Sep 24, 1993

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

Dupont Medical Products

Immunology · 59d

Cleared Sep 08, 1993

ENCORE ENA COMBINED EIA

Clark Laboratories, Inc.

Immunology · 163d

Cleared Sep 08, 1993

EYE SPOT IM TEST

J.S. Medical Assoc.

Immunology · 97d

Cleared Sep 08, 1993

RADIAS FERRITIN ENZYME IMMUNOASSAY

Immunology · 63d

Cleared Sep 01, 1993

BECKMAN VIGIL PLUS CONTROL

Beckman Instruments, Inc.

Immunology · 195d

Cleared Aug 23, 1993

EYE SPOT CRP TEST

J.S. Medical Assoc.

Immunology · 110d

Cleared Aug 23, 1993

SYLNELISA HISTONE ANTIBODIES

Elias U.S.A., Inc.

Immunology · 103d

Cleared Aug 23, 1993

EYE SPOT RF TEST

J & S Medical Assoc., Inc.

Immunology · 96d

Cleared Aug 23, 1993

RHEUMELISA II HISTONE ANTIBODY TEST KIT

Biowhittaker Molecular Applications,...

Immunology · 82d