Cleared Traditional

TOXOGEN

K981263 · Instrumentation Laboratory CO · Microbiology
Aug 1998
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K981263 is an FDA 510(k) clearance for the TOXOGEN, a Antigens, Iha, Toxoplasma Gondii (Class II — Special Controls, product code GMM), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 6, 1998, 121 days after receiving the submission on April 7, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K981263 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1998
Decision Date August 06, 1998
Days to Decision 121 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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