MODIFIED IMIPENEM SUSCEPTIBILITY POWDER— 510(k) K880574

Name: FDA 510(k) clearance K880574
Creator: U.S. Food and Drug Administration
Published: 1988-05-04

Substantially Equivalent

Merck, Sharp & Dohme

FDA 510(k) clearance K880574 for MODIFIED IMIPENEM SUSCEPTIBILITY POWDER, Substantially Equivalent on 1988-05-04. Applicant: Merck, Sharp & Dohme. Device class: 2.

Clearance details

Applicant: Merck, Sharp & Dohme
Product code: Code JTT
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1988-02-10
Decision date: 1988-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Point, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.