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FDA 510(k)

HUMAPEN LUXURA HD

K-Number: K100988 · 2010-08-17

ApplicantEli Lilly and Company
Decision Date2010-08-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HUMAPEN LUXURA HD is the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K100988. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAPEN LUXURA HD?

HUMAPEN LUXURA HD is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Eli Lilly and Company. The 510(k) number is K100988.

When did HUMAPEN LUXURA HD receive FDA 510(k) clearance?

HUMAPEN LUXURA HD received FDA 510(k) clearance on 2010-08-17, under 510(k) number K100988.

Who is the listed applicant for HUMAPEN LUXURA HD?

The FDA 510(k) record lists Eli Lilly and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAPEN LUXURA HD?

The FDA product code for HUMAPEN LUXURA HD is FMF.

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Other records listing Eli Lilly and Company as applicant

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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Related Devices (Code: FMF)

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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