Cleared Traditional

HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT

K852931 · Microbix Biosystems, Inc. · Microbiology
Nov 1985
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K852931 is an FDA 510(k) clearance for the HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT, a Antisera, Cf, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQO), submitted by Microbix Biosystems, Inc. (Canada, CA). The FDA issued a Cleared decision on November 12, 1985, 126 days after receiving the submission on July 9, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K852931 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1985
Decision Date November 12, 1985
Days to Decision 126 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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