QCA HEMOGLOBIN KIT— 510(k) K843695

Name: FDA 510(k) clearance K843695
Creator: U.S. Food and Drug Administration
Published: 1984-12-17

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K843695 for QCA HEMOGLOBIN KIT, Substantially Equivalent on 1984-12-17. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1984-09-19
Decision date: 1984-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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