FDA 510(k)

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK

K-Number: K981099 · 1998-05-26

Decision Date1998-05-26

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB 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 1998-05-26 under 510(k) number K981099. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK?

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK is a medical device that received FDA 510(k) clearance on 1998-05-26. The listed applicant is Dade Behring, Inc.. The 510(k) number is K981099.

When did STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK receive FDA 510(k) clearance?

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK received FDA 510(k) clearance on 1998-05-26, under 510(k) number K981099.

Who is the listed applicant for STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB 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 STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK?

The FDA product code for STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK is JHX.

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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.