D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT— 510(k) K093233

Name: FDA 510(k) clearance K093233
Creator: U.S. Food and Drug Administration
Published: 2009-12-04

Substantially Equivalent

Diagnostic Hybrids, Inc.

FDA 510(k) clearance K093233 for D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT, Substantially Equivalent on 2009-12-04. 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: 2009-10-14
Decision date: 2009-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

Download summary PDF View on FDA.gov ↗

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