FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×

3,792 results

2257–2280 of 3,792

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

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

Cleared Apr 26, 1990

NOVA LITE(TM) ANA MK

Inova Diagnostics, Inc.

Immunology · 21d

Cleared Apr 26, 1990

APOLIPOPROTEIN A-I (APO A-I)

Sigma Chemical Co.

Immunology · 16d