Cleared Traditional

DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM

K021394 · Diamedix Corp. · Immunology
Jul 2002
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K021394 is an FDA 510(k) clearance for the DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on July 9, 2002, 68 days after receiving the submission on May 2, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K021394 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2002
Decision Date July 09, 2002
Days to Decision 68 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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