MUCOLYSE— 510(k) K850300

Substantially Equivalent

Pro-Lab, Inc.

FDA 510(k) clearance K850300 for MUCOLYSE, Substantially Equivalent on 1985-03-20. Applicant: Pro-Lab, Inc.. Device class: 1.

Clearance details

Applicant: Pro-Lab, Inc.
Product code: Code JSK
Device class: Class 1
Regulation: 21 CFR 866.2450
Advisory panel: Microbiology
Date received: 1985-01-22
Decision date: 1985-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario Canada M5m 1c9, CA

Download summary PDF View on FDA.gov ↗

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