CULTURETTE BRAND-PVA/FORMALIN KIT— 510(k) K792654

Name: FDA 510(k) clearance K792654
Creator: U.S. Food and Drug Administration
Published: 1980-01-24

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K792654 for CULTURETTE BRAND-PVA/FORMALIN KIT, Substantially Equivalent on 1980-01-24. Applicant: Marion Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Marion Laboratories, Inc.
Product code: Code IFQ
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1979-12-26
Decision date: 1980-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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