D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT— 510(k) K081928

Substantially Equivalent

Diagnostic Hybrids, Inc.

FDA 510(k) clearance K081928 for D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT, Substantially Equivalent on 2008-12-23. Applicant: Diagnostic Hybrids, Inc..

Clearance details

Applicant: Diagnostic Hybrids, Inc.
Product code: Code LKT
Advisory panel: Microbiology
Date received: 2008-07-07
Decision date: 2008-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

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