Cleared Traditional

K061101 - D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
(FDA 510(k) Clearance)

K061101 · Diagnostic Hybrids, Inc. · Microbiology

Nov 2006

Decision

214d

Days

Class 1

Risk

K061101 is an FDA 510(k) clearance for the 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 November 20, 2006, 214 days after receiving the submission on April 20, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number	K061101 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2006
Decision Date	November 20, 2006
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF