REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK— 510(k) K955669

Name: FDA 510(k) clearance K955669
Creator: U.S. Food and Drug Administration
Published: 1996-02-23

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K955669 for REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK, Substantially Equivalent on 1996-02-23. Applicant: Remel Co.. Device class: 2.

Clearance details

Applicant: Remel Co.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1995-12-13
Decision date: 1996-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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