Cleared Traditional

DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM

K993294 · Diamedix Corp. · Immunology
Oct 1999
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K993294 is an FDA 510(k) clearance for the DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on October 25, 1999, 24 days after receiving the submission on October 1, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K993294 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1999
Decision Date October 25, 1999
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

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