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FDA 510(k), K093548, AVIE A1C TEST SYSTEM
FDA 510(k), K093548, AVIE A1C TEST SYSTEM
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510(K) Number: K093548
Device Name: AVIE A1C TEST SYSTEM
Manufacturer: MEC DYNAMICS CORP
Device Classification Name: assay, glycosylated hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 11/17/2009
Decision Date: 07/20/2011
Regulation Medical Specialty: Hematology
Device Name: AVIE A1C TEST SYSTEM
Manufacturer: MEC DYNAMICS CORP
Device Classification Name: assay, glycosylated hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 11/17/2009
Decision Date: 07/20/2011
Regulation Medical Specialty: Hematology
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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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