Cleared Traditional

ACCURUN 146 CMV IGM POSITIVE CONTROL

K972884 · Boston Biomedica, Inc. · Microbiology
Aug 1997
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K972884 is an FDA 510(k) clearance for the ACCURUN 146 CMV IGM POSITIVE CONTROL, a Antibody Igm,if, Cytomegalovirus Virus (Class II — Special Controls, product code LKQ), submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on August 22, 1997, 17 days after receiving the submission on August 5, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K972884 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1997
Decision Date August 22, 1997
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LKQ — Antibody Igm,if, Cytomegalovirus Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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