Cleared Traditional

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

K981913 · Chembio Diagnostic Systems, Inc. · Microbiology
Feb 1999
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K981913 is an FDA 510(k) clearance for the PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Chembio Diagnostic Systems, Inc. (Stoneybrook, US). The FDA issued a Cleared decision on February 12, 1999, 256 days after receiving the submission on June 1, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K981913 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1998
Decision Date February 12, 1999
Days to Decision 256 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSR — Reagent, Borrelia Serological Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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