FDA 510(k), K070666, GENESISCS COMPONENT CONCENTRATING SYSTEM
FDA 510(k), K070666, GENESISCS COMPONENT CONCENTRATING SYSTEM
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510(K) Number: K070666
Device Name: GENESISCS COMPONENT CONCENTRATING SYSTEM
Manufacturer: PERFUSION PARTNERS & ASSOC. INC.
Device Classification Name: centrifuges (micro, ultra, refrigerated) for clinical use
Regulation Number: 862.2050
Classification Product Code: JQC
Date Received: 03/12/2007
Decision Date: 06/20/2007
Regulation Medical Specialty: Clinical Chemistry
Device Name: GENESISCS COMPONENT CONCENTRATING SYSTEM
Manufacturer: PERFUSION PARTNERS & ASSOC. INC.
Device Classification Name: centrifuges (micro, ultra, refrigerated) for clinical use
Regulation Number: 862.2050
Classification Product Code: JQC
Date Received: 03/12/2007
Decision Date: 06/20/2007
Regulation Medical Specialty: Clinical Chemistry
- 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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