AFFINITY PRG— 510(k) K920230

Name: FDA 510(k) clearance K920230
Creator: U.S. Food and Drug Administration
Published: 1992-02-18

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K920230 for AFFINITY PRG, Substantially Equivalent on 1992-02-18. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1992-01-17
Decision date: 1992-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

Download summary PDF View on FDA.gov ↗

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