Cleared Traditional

MDI DS-DNA TEST

K000477 · Micro Detect, Inc. · Immunology
Mar 2000
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K000477 is an FDA 510(k) clearance for the MDI DS-DNA TEST, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on March 1, 2000, 16 days after receiving the submission on February 14, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K000477 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2000
Decision Date March 01, 2000
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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