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FDA 510(k), K151589, BD MAX CT/GC/TV, BD MAX INSTRUMENT
FDA 510(k), K151589, BD MAX CT/GC/TV, BD MAX INSTRUMENT
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$149.00 USD
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$149.00 USD
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510(K) Number: K151589
Device Name: BD MAX CT/GC/TV, BD MAX INSTRUMENT
Manufacturer: KATIE COYLE
Device Classification Name: Trichomonas Vaginalis Nucleic Acid Amplification Test System
Regulation Number: OUY
Classification Product Code: 06/12/2015
Date Received: 09/06/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: BD MAX CT/GC/TV, BD MAX INSTRUMENT
Manufacturer: KATIE COYLE
Device Classification Name: Trichomonas Vaginalis Nucleic Acid Amplification Test System
Regulation Number: OUY
Classification Product Code: 06/12/2015
Date Received: 09/06/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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