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

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..

Clearance details

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

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