ANOKRYO— 510(k) K964634

Substantially Equivalent

Mk Conquest Intl., Inc.

FDA 510(k) clearance K964634 for ANOKRYO, Substantially Equivalent on 1997-06-06. Applicant: Mk Conquest Intl., Inc.. Device class: 1.

Clearance details

Applicant: Mk Conquest Intl., Inc.
Product code: Code FFP
Device class: Class 1
Regulation: 21 CFR 876.5450
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-19
Decision date: 1997-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, 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.