Cleared Special

K092300 - MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
(FDA 510(k) Clearance)

K092300 · Diagnostic Hybrids, Inc. · Microbiology

Aug 2009

Decision

30d

Days

Class 1

Risk

K092300 is an FDA 510(k) clearance for the MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT, a Antisera, Cf, Influenza Virus A, B, C (Class I — General Controls, product code GNW), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on August 28, 2009, 30 days after receiving the submission on July 29, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number	K092300 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2009
Decision Date	August 28, 2009
Days to Decision	30 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF