Cleared Traditional

ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL

K974809 · Boston Biomedica, Inc. · Microbiology
Feb 1998
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K974809 is an FDA 510(k) clearance for the ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL, 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 February 5, 1998, 44 days after receiving the submission on December 23, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K974809 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1997
Decision Date February 05, 1998
Days to Decision 44 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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