GASTRIN RADIOIMMUNOASSAY KIT (125-I)— 510(k) K821175

Name: FDA 510(k) clearance K821175
Creator: U.S. Food and Drug Administration
Published: 1982-05-14

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K821175 for GASTRIN RADIOIMMUNOASSAY KIT (125-I), Substantially Equivalent on 1982-05-14. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CGC
Device class: Class 1
Regulation: 21 CFR 862.1325
Advisory panel: Clinical Chemistry
Date received: 1982-04-26
Decision date: 1982-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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