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Alere Scarborough, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories5
Latest FDA decision2019-03-18
TypeNumberDevice NameCodeDateActions
510(k) K190204 ID NOW Influenza A & B 2OZE2019-03-18 View
510(k) K181853 Alere BinaxNOW Influenza A & B Card 2, Alere ReaderPSZ2018-08-08 View
510(k) K173653 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitPGX2018-05-02 View
510(k) K173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2OCC2018-01-26 View
510(k) K173502 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitPSZ2017-12-13 View
510(k) K171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC2017-09-29 View
510(k) K162642 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitPSZ2017-04-10 View
510(k) K163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentOCC2016-12-21 View
510(k) K161375 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitOCC2016-08-18 View
510(k) K161364 BinaxNOW G6PD TestJBF2016-06-17 View
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