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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
Date Classified to: 09/02/2014 510(K) Number: K120413
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Product Description
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Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RS... 2 Jul-01-2014 Focus Diagnostics Inc
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis o... 2 Mar-05-2014 Focus Diagnostics Inc
Simplexa" Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV... 2 Jan-28-2014 Focus Diagnostics Inc