Cleared Traditional

ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL

K974811 · Boston Biomedica, Inc. · Microbiology
Feb 1998
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K974811 is an FDA 510(k) clearance for the ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on February 10, 1998, 49 days after receiving the submission on December 23, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K974811 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1997
Decision Date February 10, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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