REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK— 510(k) K933657

Name: FDA 510(k) clearance K933657
Creator: U.S. Food and Drug Administration
Published: 1993-10-28

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K933657 for REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK, Substantially Equivalent on 1993-10-28. 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: 1993-07-27
Decision date: 1993-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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