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FDA 510(k), K182078, MiniCollect K2E K2EDTA Tubes
FDA 510(k), K182078, MiniCollect K2E K2EDTA Tubes
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$149.00 USD
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$149.00 USD
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510(K) Number: K182078
Device Name: MiniCollect K2E K2EDTA Tubes
Manufacturer: Manfred Abel
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: 08/02/2018
Date Received: 01/25/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: MiniCollect K2E K2EDTA Tubes
Manufacturer: Manfred Abel
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: 08/02/2018
Date Received: 01/25/2019
Decision Date: Substantially Equivalent (SESE)
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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