Cleared Traditional

TOXOPLASMA GONDII SEROLOGICAL REAGENTS

K803134 · Microbiological Research Corp. · Microbiology
Jan 1981
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K803134 is an FDA 510(k) clearance for the TOXOPLASMA GONDII SEROLOGICAL REAGENTS, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1981, 48 days after receiving the submission on December 12, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K803134 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1980
Decision Date January 29, 1981
Days to Decision 48 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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