Cleared Traditional

IS-VZU IGG TEST SYSTEM

K981867 · Diamedix Corp. · Microbiology
Sep 1998
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K981867 is an FDA 510(k) clearance for the IS-VZU IGG TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 28, 1998, 123 days after receiving the submission on May 28, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K981867 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1998
Decision Date September 28, 1998
Days to Decision 123 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

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