PLATELIA LYME IGG ASSAY— 510(k) K080012

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K080012 for PLATELIA LYME IGG ASSAY, Substantially Equivalent on 2008-05-08. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2008-01-03
Decision date: 2008-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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