IMIPENEM 10 MCG SENSITIVITY DISCS— 510(k) K855207

Name: FDA 510(k) clearance K855207
Creator: U.S. Food and Drug Administration
Published: 1986-03-06

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K855207 for IMIPENEM 10 MCG SENSITIVITY DISCS, Substantially Equivalent on 1986-03-06. Applicant: Difco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code JTT
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1985-12-30
Decision date: 1986-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

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