BACTEC BACTERIAL DETECTION SYSTEM: #5— 510(k) K810042

Name: FDA 510(k) clearance K810042
Creator: U.S. Food and Drug Administration
Published: 1981-01-28

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K810042 for BACTEC BACTERIAL DETECTION SYSTEM: #5, Substantially Equivalent on 1981-01-28. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JTA
Device class: Class 1
Regulation: 21 CFR 866.2560
Advisory panel: Microbiology
Date received: 1981-01-07
Decision date: 1981-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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