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FDA 510(k), K080552, CYTO-CHEX BCT
FDA 510(k), K080552, CYTO-CHEX BCT
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510(K) Number: K080552
Device Name: CYTO-CHEX BCT
Manufacturer: CARL THOMPSON
Device Classification Name: Tubes, Vacuum Sample, With Anticoagulant
Regulation Number: GIM
Classification Product Code: 02/28/2008
Date Received: 07/31/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: CYTO-CHEX BCT
Manufacturer: CARL THOMPSON
Device Classification Name: Tubes, Vacuum Sample, With Anticoagulant
Regulation Number: GIM
Classification Product Code: 02/28/2008
Date Received: 07/31/2008
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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