Cleared Traditional

K070206 - DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
(FDA 510(k) Clearance)

K070206 · Diagnostic Hybrids, Inc. · Microbiology

Aug 2007

Decision

220d

Days

Class 2

Risk

K070206 is an FDA 510(k) clearance for the DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000, a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II — Special Controls, product code GQW), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on August 30, 2007, 220 days after receiving the submission on January 22, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number	K070206 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2007
Decision Date	August 30, 2007
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF