LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM— 510(k) K082050

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K082050 for LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM, Substantially Equivalent on 2008-11-03. Applicant: DiaSorin, Inc.. Device class: 2.

Clearance details

Applicant
DiaSorin, Inc.
Product code
Code LOL
Device class
Class 2
Regulation
21 CFR 866.3310
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stillwater, MN, US
Download summary PDFView on FDA.gov ↗

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