Cleared Traditional

TOXO BIO-BEAD TITRATION KIT

K801720 · Litton Bionetics · Microbiology
Sep 1980
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K801720 is an FDA 510(k) clearance for the TOXO BIO-BEAD TITRATION 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 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 866.3780.

Submission Details

510(k) Number K801720 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 GLZ — Antigens, If, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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