DIRECTIGEN GROUP A STREP TEST KIT— 510(k) K843713

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K843713 for DIRECTIGEN GROUP A STREP TEST KIT, Substantially Equivalent on 1985-01-04. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1984-09-21
Decision date: 1985-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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