Cleared Traditional

IMMUNOZYME TOXOPLASMA ANTIBODY

K780352 · Millipore Corp. · Microbiology
Jun 1978
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K780352 is an FDA 510(k) clearance for the IMMUNOZYME TOXOPLASMA ANTIBODY, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1978, 117 days after receiving the submission on March 3, 1978. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K780352 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1978
Decision Date June 28, 1978
Days to Decision 117 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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