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FDA 510(k), K183230, OneDraw A1C Test System
FDA 510(k), K183230, OneDraw A1C Test System
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$149.00 USD
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510(K) Number: K183230
Device Name: OneDraw A1C Test System
Manufacturer: Annie Wright
Device Classification Name: Assay, Glycosylated Hemoglobin
Regulation Number: LCP
Classification Product Code: 11/20/2018
Date Received: 08/15/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: OneDraw A1C Test System
Manufacturer: Annie Wright
Device Classification Name: Assay, Glycosylated Hemoglobin
Regulation Number: LCP
Classification Product Code: 11/20/2018
Date Received: 08/15/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- 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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