Cleared Traditional

TOXO IGM TEST

K880007 · Gull Laboratories, Inc. · Microbiology
Mar 1988
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K880007 is an FDA 510(k) clearance for the TOXO IGM TEST, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 17, 1988, 73 days after receiving the submission on January 4, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K880007 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1988
Decision Date March 17, 1988
Days to Decision 73 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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