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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K140068
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PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying... 2 01/21/2020 Polymer Technology Systems, Inc.
PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Refe... 2 01/21/2020 Polymer Technology Systems, Inc.
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 2 01/21/2020 Polymer Technology Systems, Inc.
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Referen... 2 01/21/2020 Polymer Technology Systems, Inc.
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