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FDA 510(k)

STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK

K-Number: K984093 · 1998-12-14

ApplicantDade Behring, Inc.
Decision Date1998-12-14
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS (R) CS CARDIAC TROPONIN I (TROP) 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 1998-12-14 under 510(k) number K984093. 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 (R) CS CARDIAC TROPONIN I (TROP) TESTPAK?

STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK is a medical device that received FDA 510(k) clearance on 1998-12-14. The listed applicant is Dade Behring, Inc.. The 510(k) number is K984093.

When did STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK receive FDA 510(k) clearance?

STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK received FDA 510(k) clearance on 1998-12-14, under 510(k) number K984093.

Who is the listed applicant for STRATUS (R) CS CARDIAC TROPONIN I (TROP) 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 (R) CS CARDIAC TROPONIN I (TROP) TESTPAK?

The FDA product code for STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK 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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