PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM— 510(k) K881774

Name: FDA 510(k) clearance K881774
Creator: U.S. Food and Drug Administration
Published: 1988-06-08

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K881774 for PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM, Substantially Equivalent on 1988-06-08. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1988-04-26
Decision date: 1988-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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