UN, UV DELTA TEST ASSAY— 510(k) K770654

Name: FDA 510(k) clearance K770654
Creator: U.S. Food and Drug Administration
Published: 1977-06-24

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K770654 for UN, UV DELTA TEST ASSAY, 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 CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
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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