FDA 510(k), K163406, Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
FDA 510(k), K163406, Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
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510(K) Number: K163406
Device Name: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
Manufacturer: ACON LABORATORIES INC.
Device Classification Name: Enzymatic Esterase--Oxidase, Cholesterol
Regulation Number: 862.1175
Classification Product Code: CHH
Date Received: 12/05/2016
Decision Date: 07/11/2017
Regulation Medical Specialty: Clinical Chemistry
Device Name: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
Manufacturer: ACON LABORATORIES INC.
Device Classification Name: Enzymatic Esterase--Oxidase, Cholesterol
Regulation Number: 862.1175
Classification Product Code: CHH
Date Received: 12/05/2016
Decision Date: 07/11/2017
Regulation Medical Specialty: Clinical Chemistry
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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