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
2185–2208 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 09, 1991
RAICHEM SPIA C3 REAGENT
K911900 · CZW
Reagents Applications, Inc.
Immunology · 13d
Cleared May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
K910553 · DER
Roche Diagnostic Systems, Inc.
Immunology · 90d
Cleared May 08, 1991
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898 · DAD
Reagents Applications, Inc.
Immunology · 12d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · MSJ
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · MSJ
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared May 07, 1991
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848 · LKP
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849 · LKO
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850 · LKO
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNOWELL SM ANTIBODY TEST
K911851 · LKP
General Biometrics, Inc.
Immunology · 11d
Cleared Apr 24, 1991
PHARMACIA SPECIFIC IGE CONTROL
K911631 · DGC
Pharmacia, Inc.
Immunology · 13d
Cleared Apr 17, 1991
ALLERGEN MODULES FOR ALASTAT TM
K894227 · DHB
Diagnostic Products Corp.
Immunology · 667d
Cleared Apr 17, 1991
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
K911511 · DGO
Diagnostic Products Corp.
Immunology · 13d
Cleared Apr 12, 1991
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535 · DCN
Beckman Instruments, Inc.
Immunology · 63d
Cleared Apr 05, 1991
NA ALPHA 1 MICROGLOBULIN KIT
K904254 · JZG
Behring Diagnostics, Inc.
Immunology · 203d
Cleared Apr 05, 1991
MAST CLA ALLERGY SYSTEM
K910292 · DHB
Mast Immunosystems
Immunology · 72d
Cleared Apr 05, 1991
RHEUMAJET RF
K910539 · DHR
Biokit USA, Inc.
Immunology · 67d
Cleared Apr 05, 1991
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175 · DBF
Serono-Baker Diagnostics, Inc.
Immunology · 18d
Cleared Mar 22, 1991
CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER
K905054 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 134d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-R
K910122 · KLN
V-Tech, Inc.
Immunology · 67d
Cleared Mar 19, 1991
RHEUMAJET CRP
K910686 · DCN
Biokit USA, Inc.
Immunology · 28d
Cleared Mar 12, 1991
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770 · DBF
Ciba Corning Diagnostics Corp.
Immunology · 75d
Cleared Mar 12, 1991
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
K910082 · DGC
Quidel Corp.
Immunology · 63d
Cleared Mar 06, 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · JZG
Diagnostic Products Corp.
Immunology · 58d
Cleared Mar 06, 1991
HEMAGEN ENA SCREENING KIT
K910232 · LLL
Hemagen Diagnostics, Inc.
Immunology · 47d