Cleared Traditional

ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL

K974261 · Boston Biomedica, Inc. · Microbiology
Dec 1997
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K974261 is an FDA 510(k) clearance for the ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL, a Antisera, If, Toxoplasma Gondii (Class II — Special Controls, product code LJK), submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on December 11, 1997, 28 days after receiving the submission on November 13, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K974261 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1997
Decision Date December 11, 1997
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJK — Antisera, If, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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