Cleared Traditional

DIAMEDIX IS-RF TEST SYSTEM

K974889 · Diamedix Corp. · Immunology
Mar 1998
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K974889 is an FDA 510(k) clearance for the DIAMEDIX IS-RF 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 March 6, 1998, 66 days after receiving the submission on December 30, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K974889 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1997
Decision Date March 06, 1998
Days to Decision 66 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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