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

1681–1704 of 3,794

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

Cleared Mar 12, 1996

HEMAGEN CRP 150 KIT (EIA METHOD)

Hemagen Diagnostics, Inc.

Immunology · 49d

Cleared Mar 06, 1996

THERATEST KIT (MODIFICATION)

Theratest Laboratories, Inc.

Immunology · 112d

Cleared Feb 29, 1996

QUANTA LITE SSDNA

Inova Diagnostics, Inc.

Immunology · 163d

Cleared Feb 27, 1996

CHEMMATE SPECIAL STAIN LCA-CD45

Biotek Solutions, Inc.

Immunology · 796d

Cleared Feb 26, 1996

KERATIN PRIMARY ANTIBODY

Ventana Medical Systems, Inc.

Immunology · 763d

Cleared Feb 21, 1996

N PROTEIN STANDARS SY

Behring Diagnostics, Inc.

Immunology · 56d

Cleared Feb 21, 1996

N/T PROTEIN CONTROL SY/L, M AND H

Behring Diagnostics, Inc.

Immunology · 56d

Cleared Feb 16, 1996

WAKO AUTOKIT CRP NEW

Wako Chemicals USA, Inc.

Immunology · 95d

Cleared Feb 16, 1996

SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM

Beckman Instruments, Inc.

Immunology · 66d

Cleared Feb 14, 1996

OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT

Olympus America, Inc.

Immunology · 138d

Cleared Feb 14, 1996

IMMILITE TOTAL IGE

Diagnostic Products Corp.

Immunology · 40d

Cleared Feb 09, 1996

CARDIOLIPIN IGM EIA TEST SYSTEM

Immunoprobe, Inc.

Immunology · 253d

Cleared Feb 09, 1996

CARDIOLIPIN IGA EIA TEST SYSTEM

Immunoprobe, Inc.

Immunology · 253d

Cleared Feb 09, 1996

CARDIOLIPIN IGG EIA TEST KIT

Immunoprobe, Inc.

Immunology · 253d

Cleared Feb 09, 1996

BOEHRINGER MANNHEIM IGG ASSAY

Boehringer Mannheim Corp.

Immunology · 42d

Cleared Feb 09, 1996

BOEHRINGER MANNHEIM IGA ASSAY

Boehringer Mannheim Corp.

Immunology · 42d

Cleared Feb 09, 1996

BOEHRINGER MANNHEIM IGM ASSAY

Boehringer Mannheim Corp.

Immunology · 42d

Cleared Jan 30, 1996

PHARMACIA CAP SYSTEM PHADIATOP FEIA

Pharmacia, Inc.

Immunology · 645d

Cleared Jan 30, 1996

HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT

The Binding Site, Ltd.

Immunology · 433d

Cleared Jan 30, 1996

HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT

The Binding Site, Ltd.

Immunology · 433d

Cleared Jan 30, 1996

HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT

The Binding Site, Ltd.

Immunology · 433d

Cleared Jan 26, 1996

VARELISA PR3-ANCA

Elias U.S.A., Inc.

Immunology · 178d

Cleared Jan 26, 1996

VARELISA MPO-ANCA

Elias U.S.A., Inc.

Immunology · 178d

Cleared Jan 24, 1996

CARDIOLIPIN G EIA TEST SYSTEM

Hogan & Hartson

Immunology · 399d