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FDA 510(k)

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK

K-Number: K062924 · 2006-12-26

ApplicantDade Behring, Inc.
Decision Date2006-12-26
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-12-26 under 510(k) number K062924. The device is classified under product code NQD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK?

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK is a medical device that received FDA 510(k) clearance on 2006-12-26. The listed applicant is Dade Behring, Inc.. The 510(k) number is K062924.

When did STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK receive FDA 510(k) clearance?

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK received FDA 510(k) clearance on 2006-12-26, under 510(k) number K062924.

Who is the listed applicant for STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK?

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

What is the FDA product code for STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK?

The FDA product code for STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK is NQD.

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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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