Cleared Traditional

MDI RF TEST

K993843 · Micro Detect, Inc. · Immunology
Jan 2000
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K993843 is an FDA 510(k) clearance for the MDI RF TEST, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on January 11, 2000, 60 days after receiving the submission on November 12, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K993843 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1999
Decision Date January 11, 2000
Days to Decision 60 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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