Cleared Traditional

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM

K001707 · Diamedix Corp. · Microbiology
Jul 2000
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K001707 is an FDA 510(k) clearance for the DIAMEDIX IS-TOXOPLASMA IGM CAPTURE 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 July 7, 2000, 32 days after receiving the submission on June 5, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K001707 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2000
Decision Date July 07, 2000
Days to Decision 32 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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