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

745–768 of 3,794

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

Cleared Sep 10, 2003

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT

Kronus Market Development Associates,...

Immunology · 61d

Cleared Sep 10, 2003

MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

Roche Diagnostics Corp.

Immunology · 23d

Cleared Sep 09, 2003

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA

Immco Diagnostics, Inc.

Immunology · 187d

Cleared Sep 09, 2003

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA

Immco Diagnostics, Inc.

Immunology · 187d

Cleared Sep 05, 2003

N/T PROTEIN CONTROL

Dade Behring, Inc.

Immunology · 46d

Cleared Aug 29, 2003

IBL C1Q-CIC CIA TEST

Immunology · 38d

Cleared Aug 07, 2003

Dade Behring, Inc.

Immunology · 38d

Cleared Aug 07, 2003

SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS...

Beckman Coulter, Inc.

Immunology · 37d

Cleared Jul 23, 2003

LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS

Cliniqa Corporation

Immunology · 64d

Cleared Jul 17, 2003

FERRITIN GENERATION 2

Roche Diagnostics Corp.

Immunology · 50d

Cleared Jul 15, 2003

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING...

The Binding Site, Ltd.

Immunology · 106d

Cleared Jul 07, 2003

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

Immunology · 81d

Cleared Jun 25, 2003

QUANTA PLEX ENA PROFILE 6

Inova Diagnostics, Inc.

Immunology · 49d

Cleared Jun 24, 2003

BAYER ADVIA CENTAUR CA 19-9 ASSAY

Bayer Healthcare, LLC

Immunology · 53d

Cleared Jun 19, 2003

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

Axis-Shield Diagnostics, Ltd.

Immunology · 66d

Cleared Jun 02, 2003

CRP-LATEX (II)X2 SEIKEN ASSAY KIT

Denka Seiken Co., Ltd.

Immunology · 102d

Cleared Jun 02, 2003

CRP (II) CALIBRATORS

Denka Seiken Co., Ltd.

Immunology · 102d

Cleared May 15, 2003

TPSA FLEX REAGENT CARTRIDGE

Dade Behring, Inc.

Immunology · 16d

Cleared May 12, 2003

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

Immuno Concepts, N.A. , Ltd.

Immunology · 62d

Cleared May 06, 2003

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

Beckman Coulter, Inc.

Immunology · 15d

Cleared May 02, 2003

Orgentec Diagnostika GmbH

Immunology · 39d

Cleared May 02, 2003

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Beckman Coulter, Inc.

Immunology · 11d

Cleared May 02, 2003

ACCESS OV MONITOR ASSAY

Beckman Coulter, Inc.

Immunology · 8d

Cleared May 01, 2003

AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

Hycor Biomedical , Ltd.

Immunology · 52d