LATELET, CONTROL, NORMAL & ABNORMAL— 510(k) K770386

Name: FDA 510(k) clearance K770386
Creator: U.S. Food and Drug Administration
Published: 1977-03-21

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K770386 for LATELET, CONTROL, NORMAL & ABNORMAL, Substantially Equivalent on 1977-03-21. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1977-02-28
Decision date: 1977-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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