Cleared Traditional

D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT

K081164 · Diagnostic Hybrids, Inc. · Microbiology
Jun 2008
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K081164 is an FDA 510(k) clearance for the D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on June 13, 2008, 50 days after receiving the submission on April 24, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K081164 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2008
Decision Date June 13, 2008
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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