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FDA 510(k)

CUMULASE

K-Number: K042495 · 2005-04-14

ApplicantHalozyme Therapeutics, Inc.
Decision Date2005-04-14
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CUMULASE is the device name listed in this FDA 510(k) record. The listed applicant is Halozyme Therapeutics, Inc.. It received FDA 510(k) clearance on 2005-04-14 under 510(k) number K042495. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUMULASE?

CUMULASE is a medical device that received FDA 510(k) clearance on 2005-04-14. The listed applicant is Halozyme Therapeutics, Inc.. The 510(k) number is K042495.

When did CUMULASE receive FDA 510(k) clearance?

CUMULASE received FDA 510(k) clearance on 2005-04-14, under 510(k) number K042495.

Who is the listed applicant for CUMULASE?

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

What is the FDA product code for CUMULASE?

The FDA product code for CUMULASE is MQL.

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Related Devices (Code: MQL)

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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