FOLATE REAGENT KIT, ARIA-II SYSTEM— 510(k) K780557

Name: FDA 510(k) clearance K780557
Creator: U.S. Food and Drug Administration
Published: 1978-05-18

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K780557 for FOLATE REAGENT KIT, ARIA-II SYSTEM, Substantially Equivalent on 1978-05-18. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1978-04-05
Decision date: 1978-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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