CULTURETTE BRAND TOXIN CD TEST— 510(k) K925329

Name: FDA 510(k) clearance K925329
Creator: U.S. Food and Drug Administration
Published: 1993-03-24

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K925329 for CULTURETTE BRAND TOXIN CD TEST, Substantially Equivalent on 1993-03-24. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1992-10-21
Decision date: 1993-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, NE, US

Download summary PDF View on FDA.gov ↗

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