Cleared Traditional

DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM

K980759 · Diamedix Corp. · Immunology
Apr 1998
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K980759 is an FDA 510(k) clearance for the DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on April 23, 1998, 55 days after receiving the submission on February 27, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K980759 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1998
Decision Date April 23, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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