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FDA 510(k)

KANEKA PHARMA AMERICA XPRESS-WAY RX

K-Number: K101839 · 2010-10-22

ApplicantKaneka Pharma America, LLC
Decision Date2010-10-22
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KANEKA PHARMA AMERICA XPRESS-WAY RX is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Pharma America, LLC. It received FDA 510(k) clearance on 2010-10-22 under 510(k) number K101839. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KANEKA PHARMA AMERICA XPRESS-WAY RX?

KANEKA PHARMA AMERICA XPRESS-WAY RX is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Kaneka Pharma America, LLC. The 510(k) number is K101839.

When did KANEKA PHARMA AMERICA XPRESS-WAY RX receive FDA 510(k) clearance?

KANEKA PHARMA AMERICA XPRESS-WAY RX received FDA 510(k) clearance on 2010-10-22, under 510(k) number K101839.

Who is the listed applicant for KANEKA PHARMA AMERICA XPRESS-WAY RX?

The FDA 510(k) record lists Kaneka Pharma America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KANEKA PHARMA AMERICA XPRESS-WAY RX?

The FDA product code for KANEKA PHARMA AMERICA XPRESS-WAY RX is QEZ.

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Other records listing Kaneka Pharma America, LLC as applicant

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Related Devices (Code: QEZ)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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