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FDA 510(k)

DAKOCYTOMATION ER/PR PHARMDX KIT

K-Number: K042884 · 2005-02-15

ApplicantDakocytomation California, Inc.
Decision Date2005-02-15
Product CodeMXZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DAKOCYTOMATION ER/PR PHARMDX KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dakocytomation California, Inc.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K042884. The device is classified under product code MXZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAKOCYTOMATION ER/PR PHARMDX KIT?

DAKOCYTOMATION ER/PR PHARMDX KIT is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Dakocytomation California, Inc.. The 510(k) number is K042884.

When did DAKOCYTOMATION ER/PR PHARMDX KIT receive FDA 510(k) clearance?

DAKOCYTOMATION ER/PR PHARMDX KIT received FDA 510(k) clearance on 2005-02-15, under 510(k) number K042884.

Who is the listed applicant for DAKOCYTOMATION ER/PR PHARMDX KIT?

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

What is the FDA product code for DAKOCYTOMATION ER/PR PHARMDX KIT?

The FDA product code for DAKOCYTOMATION ER/PR PHARMDX KIT is MXZ.

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Other records listing Dakocytomation California, Inc. as applicant

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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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