BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST— 510(k) K895362

Name: FDA 510(k) clearance K895362
Creator: U.S. Food and Drug Administration
Published: 1989-12-01

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K895362 for BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST, Substantially Equivalent on 1989-12-01. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JTT
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1989-08-29
Decision date: 1989-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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