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FDA 510(k), K191352, binx health io CT/NG Assay
FDA 510(k), K191352, binx health io CT/NG Assay
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$149.00 USD
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$149.00 USD
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510(K) Number: K191352
Device Name: binx health io CT/NG Assay
Manufacturer: Sarah Kalil
Device Classification Name: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Regulation Number: QEP
Classification Product Code: 05/20/2019
Date Received: 08/08/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: binx health io CT/NG Assay
Manufacturer: Sarah Kalil
Device Classification Name: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Regulation Number: QEP
Classification Product Code: 05/20/2019
Date Received: 08/08/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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