Cleared Traditional

HSV BIO-BEAD TITRATION KIT

K801721 · Litton Bionetics · Microbiology
Sep 1980
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K801721 is an FDA 510(k) clearance for the HSV BIO-BEAD TITRATION KIT, a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQN), submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980, 55 days after receiving the submission on July 23, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K801721 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1980
Decision Date September 16, 1980
Days to Decision 55 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQN — Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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