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FDA 510(k)

ANOKRYO

K-Number: K964634 · 1997-06-06

Decision Date1997-06-06
Product CodeFFP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANOKRYO is the device name listed in this FDA 510(k) record. The listed applicant is Mk Conquest Intl., Inc.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K964634. The device is classified under product code FFP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANOKRYO?

ANOKRYO is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Mk Conquest Intl., Inc.. The 510(k) number is K964634.

When did ANOKRYO receive FDA 510(k) clearance?

ANOKRYO received FDA 510(k) clearance on 1997-06-06, under 510(k) number K964634.

Who is the listed applicant for ANOKRYO?

The FDA 510(k) record lists Mk Conquest Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANOKRYO?

The FDA product code for ANOKRYO is FFP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FFP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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