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FDA 510(k)

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

K-Number: K033487 · 2003-12-24

ApplicantDade Behring, Inc.
Decision Date2003-12-24
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI 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 2003-12-24 under 510(k) number K033487. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI?

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI is a medical device that received FDA 510(k) clearance on 2003-12-24. The listed applicant is Dade Behring, Inc.. The 510(k) number is K033487.

When did STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI receive FDA 510(k) clearance?

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI received FDA 510(k) clearance on 2003-12-24, under 510(k) number K033487.

Who is the listed applicant for STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI?

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 TROPONIN I TESTPAK, MODEL CCTNI?

The FDA product code for STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI is MMI.

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Official Source

View on FDA Database →

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

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