QUALITY CONTROL SYSTEM, SPECTRA— 510(k) K780097

Name: FDA 510(k) clearance K780097
Creator: U.S. Food and Drug Administration
Published: 1978-04-24

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K780097 for QUALITY CONTROL SYSTEM, SPECTRA, Substantially Equivalent on 1978-04-24. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KSF
Device class: Class 2
Regulation: 21 CFR 864.9650
Advisory panel: Hematology
Date received: 1978-01-19
Decision date: 1978-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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