Cleared Traditional

BION HSV1-G OR HSV2-G TEST SYSTEM

K881261 · Bion Ent., Ltd. · Microbiology
Jun 1988
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K881261 is an FDA 510(k) clearance for the BION HSV1-G OR HSV2-G TEST SYSTEM, a Antisera, Cf, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQO), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on June 7, 1988, 75 days after receiving the submission on March 24, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K881261 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1988
Decision Date June 07, 1988
Days to Decision 75 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQO — Antisera, Cf, Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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