Cleared Traditional

IS-TOXOPLASMA IGG TEST SYSTEM

K981498 · Diamedix Corp. · Microbiology
Aug 1998
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K981498 is an FDA 510(k) clearance for the IS-TOXOPLASMA IGG TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on August 21, 1998, 116 days after receiving the submission on April 27, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K981498 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1998
Decision Date August 21, 1998
Days to Decision 116 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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