REAGENT SYSTEM, ARIA II T3 UPTAKE— 510(k) K780253

Name: FDA 510(k) clearance K780253
Creator: U.S. Food and Drug Administration
Published: 1978-03-28

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K780253 for REAGENT SYSTEM, ARIA II T3 UPTAKE, Substantially Equivalent on 1978-03-28. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1978-02-14
Decision date: 1978-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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