FDA 510(k), K040107, CYTO-CHEX BCT
FDA 510(k), K040107, CYTO-CHEX BCT
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510(K) Number: K040107
Device Name: CYTO-CHEX BCT
Manufacturer: KERRIE OETTER
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: 01/20/2004
Date Received: 07/27/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: CYTO-CHEX BCT
Manufacturer: KERRIE OETTER
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: 01/20/2004
Date Received: 07/27/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
- 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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