NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK— 510(k) K864848

Name: FDA 510(k) clearance K864848
Creator: U.S. Food and Drug Administration
Published: 1987-03-17

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K864848 for NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK, Substantially Equivalent on 1987-03-17. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1986-12-10
Decision date: 1987-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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