LATELET DETERMIBATION KIT, UL 800— 510(k) K770655

Name: FDA 510(k) clearance K770655
Creator: U.S. Food and Drug Administration
Published: 1977-06-24

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K770655 for LATELET DETERMIBATION KIT, UL 800, Substantially Equivalent on 1977-06-24. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GJP
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1977-04-06
Decision date: 1977-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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