BACTEC NR-730 BACTERIAL DETECTION SYSTEM— 510(k) K853011

Name: FDA 510(k) clearance K853011
Creator: U.S. Food and Drug Administration
Published: 1985-07-30

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K853011 for BACTEC NR-730 BACTERIAL DETECTION SYSTEM, Substantially Equivalent on 1985-07-30. 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: 1985-07-16
Decision date: 1985-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Download summary PDF View on FDA.gov ↗

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