Cleared Traditional

IS-RUBELLA IGG TEST SYSTEM

K981729 · Diamedix Corp. · Microbiology
Jan 1999
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K981729 is an FDA 510(k) clearance for the IS-RUBELLA IGG TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on January 28, 1999, 258 days after receiving the submission on May 15, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K981729 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1998
Decision Date January 28, 1999
Days to Decision 258 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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