Cleared Traditional

BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT

K980351 · Boston Biomedica, Inc. · Microbiology
Mar 1999
Decision
400d
Days
Class 2
Risk

About This 510(k) Submission

K980351 is an FDA 510(k) clearance for the BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on March 5, 1999, 400 days after receiving the submission on January 29, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K980351 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1998
Decision Date March 05, 1999
Days to Decision 400 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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