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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: JHX Applicant: DADE BEHRING, INC. Decision Date To: 05/22/2022
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stratus cs acute care mb isoenzyme of creatine kinase (ckmb) test pak; stratus cs acute care ckmb testpak. DADE BEHRING, INC. K051650 09/08/2005
stratus (r) cs stat fluorometric analyzer, stratus (r) cs ckmb test pak DADE BEHRING, INC. K984067 01/13/1999
stratus cs stat fluorometric analyzer and stratus cs ckmb testpak DADE BEHRING, INC. K981099 05/26/1998
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