Cleared Traditional

TOXOTEST-MT EIKEN KIT

K802452 · Syn-Kit, Inc. · Microbiology
Dec 1980
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K802452 is an FDA 510(k) clearance for the TOXOTEST-MT EIKEN KIT, a Antigens, Iha, Toxoplasma Gondii (Class II — Special Controls, product code GMM), submitted by Syn-Kit, Inc. (Walker, US). The FDA issued a Cleared decision on December 18, 1980, 71 days after receiving the submission on October 8, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K802452 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1980
Decision Date December 18, 1980
Days to Decision 71 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

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