D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT— 510(k) K093415

Name: FDA 510(k) clearance K093415
Creator: U.S. Food and Drug Administration
Published: 2009-12-23

Substantially Equivalent

Diagnostic Hybrids, Inc.

FDA 510(k) clearance K093415 for D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT, Substantially Equivalent on 2009-12-23. Applicant: Diagnostic Hybrids, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Hybrids, Inc.
Product code: Code GQS
Device class: Class 1
Regulation: 21 CFR 866.3400
Advisory panel: Microbiology
Date received: 2009-11-02
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQS

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K943557 — IMAGEN1995-01-09
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K884194 — PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT1988-11-22
K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 21987-06-26

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