ZITHROMAX— 510(k) K922792

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K922792 for ZITHROMAX, Substantially Equivalent on 1992-07-30. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code JNT
Device class: Class 1
Regulation: 21 CFR 862.1575
Advisory panel: Clinical Chemistry
Date received: 1992-06-09
Decision date: 1992-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, 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.