Cleared Traditional

HSV BIO-BEAD SCREEN KIT

K791614 · Litton Bionetics · Microbiology
Nov 1979
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K791614 is an FDA 510(k) clearance for the HSV BIO-BEAD SCREEN 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 November 13, 1979, 84 days after receiving the submission on August 21, 1979. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K791614 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1979
Decision Date November 13, 1979
Days to Decision 84 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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