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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 3 of 3 Results
510(K) Number: K030286
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Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled k... 1 05/08/2009 FEI # 1000125596
Biosite Inc
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase ... 1 07/06/2012 FEI # 1000125596
Alere San Diego, Inc.
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 970... 1 07/07/2023 FEI # 3013982035
QUIDEL CARDIOVASCULAR INC
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