MACRO-VUE CARD TEST— 510(k) K810597

Name: FDA 510(k) clearance K810597
Creator: U.S. Food and Drug Administration
Published: 1981-03-17

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K810597 for MACRO-VUE CARD TEST, Substantially Equivalent on 1981-03-17. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1981-03-06
Decision date: 1981-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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