D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT— 510(k) K091171

Name: FDA 510(k) clearance K091171
Creator: U.S. Food and Drug Administration
Published: 2009-09-11

Substantially Equivalent

Diagnostic Hybrids, Inc.

FDA 510(k) clearance K091171 for D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT, Substantially Equivalent on 2009-09-11. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Hybrids, Inc.
Product code: Code OMG
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2009-04-22
Decision date: 2009-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

Download summary PDF View on FDA.gov ↗

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