Cleared Traditional

ELVIS HSV ID/TYPING TEST SYSTEM

K971662 · Diagnostic Hybrids, Inc. · Microbiology
Nov 1997
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K971662 is an FDA 510(k) clearance for the ELVIS HSV ID/TYPING TEST SYSTEM, a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQN), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on November 18, 1997, 203 days after receiving the submission on April 29, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K971662 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1997
Decision Date November 18, 1997
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQN — Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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