510(k) K981913— PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

Substantially Equivalent

Chembio Diagnostic Systems, Inc.

Clearance details

Applicant: Chembio Diagnostic Systems, Inc.
Product code: Code LSR
Advisory panel: Microbiology
Date received: 1998-06-01
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, NY, US

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