Cleared Traditional

TORCH BIO-BEAD SCREEN KIT

K791618 · Litton Bionetics · Microbiology
Nov 1979
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K791618 is an FDA 510(k) clearance for the TORCH BIO-BEAD SCREEN KIT, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 85 days after receiving the submission on August 20, 1979. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K791618 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1979
Decision Date November 13, 1979
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

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