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
2185–2208 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 15, 1991
NATIVE PROTHROMBIN ANTIGEN EIA
K910617 · DDF
Organon Teknika Corp.
Immunology · 92d
Cleared May 09, 1991
RAICHEM SPIA C4 REAGENT
K911899 · DBI
Reagents Applications, Inc.
Immunology · 13d
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