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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 79 Results
510(K) Number: K113501
 
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Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) ... 2 09/30/2020 Ameditech Inc
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71... 2 11/18/2015 Ameditech Inc
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 1112... 2 11/18/2015 Ameditech Inc
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-st... 2 11/18/2015 Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step ... 2 11/18/2015 Ameditech Inc
CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Dru... 2 11/18/2015 Ameditech Inc
DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoass... 2 11/18/2015 Ameditech Inc
DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step... 2 11/18/2015 Ameditech Inc
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61... 2 11/18/2015 Ameditech Inc
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; Drug... 2 11/18/2015 Ameditech Inc
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