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Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest FDA decision2022-02-26
TypeNumberDevice NameCodeDateActions
510(k) K193406 CardioChek Plus Test System; CardioChek Plus Home Test SystemNBW2022-02-26 View
510(k) K182781 PTS Professional Chemistry KitCGA2018-12-21 View
510(k) K162282 CardioChek Plus Test System, CardioChek Home Test SystemCGA2016-12-22 View