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

2257–2280 of 3,794

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

Cleared Aug 14, 1990

READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT

Biosearch Medical Products, Inc.

Immunology · 89d

Cleared Aug 14, 1990

ANTI-SCI-70 ANTIBODY TEST

Immco Diagnostics, Inc.

Immunology · 21d

Cleared Aug 09, 1990

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3

General Biometrics, Inc.

Immunology · 37d

Cleared Aug 09, 1990

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4

General Biometrics, Inc.

Immunology · 29d

Cleared Aug 02, 1990

EQUATE(TM) AQR APO AL/B DUO CONTROL

Immunology · 17d

Cleared Aug 02, 1990

LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY

London Diagnostics, Inc.

Immunology · 14d

Cleared Jul 31, 1990

TURBO-RAST SPECIFIC IGE ASSAY

Ventrex Laboratories, Inc.

Immunology · 22d

Cleared Jul 16, 1990

UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE

United Biotech, Inc.

Immunology · 13d

Cleared Jul 09, 1990

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT

Immunology · 52d

Cleared Jun 28, 1990

MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX

Trinity Laboratories, Inc.

Immunology · 22d

Cleared Jun 28, 1990

RAICHEM(TM) SPIA(TM) CRP REAGENT

Reagents Applications, Inc.

Immunology · 16d

Cleared Jun 28, 1990

LIPOGEN RHEUMELISA DSDNA ASSAY

Immunology · 14d

Cleared Jun 21, 1990

MODIFIED QM300 RHEUMATOID FACTOR TEST

Kallestad Diag, A Div. of Erbamont, Inc.

Immunology · 17d

Cleared Jun 21, 1990

BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)

Beckman Instruments, Inc.

Immunology · 16d

Cleared Jun 21, 1990

BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)

Beckman Instruments, Inc.

Immunology · 16d

Cleared Jun 07, 1990

BEHRING LASER NEPHELOMETER

Behring Diagnostics, Inc.

Cleared Jun 06, 1990

REP(R) IMMUNOFIX

Helena Laboratories

Immunology · 47d

Cleared Jun 01, 1990

NA LATEX MYOGLOBIN TEST

Behring Diagnostics, Inc.

Immunology · 17d

Cleared May 21, 1990

PATHO DX STREP D

Diagnostic Products Corp.

Immunology · 17d

Cleared May 18, 1990

HEMAGEN ENA [JO-I] KIT

Hemagen Diagnostics, Inc.

Immunology · 9d

Cleared May 09, 1990

READS(R) ANTI-ENA (SM/RNP) TEST KIT

Biosearch Medical Products, Inc.

Immunology · 9d

Cleared May 03, 1990

COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2

Diagnostic Products Corp.

Immunology · 9d

Cleared May 02, 1990

NOVA LITE(TM) ANA KSL

Inova Diagnostics, Inc.

Immunology · 27d

Cleared Apr 26, 1990

MODIFIED TECHNICON DPA-1(TM) SYSTEM

Technicon Instruments Corp.

Immunology · 57d