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FDA 510(k), K831004, AUTOMATED 8400 BLOOD CELL SEPARATOR
FDA 510(k), K831004, AUTOMATED 8400 BLOOD CELL SEPARATOR
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510(K) Number: K831004
Device Name: AUTOMATED 8400 BLOOD CELL SEPARATOR
Manufacturer: INTL. BUSINESS MACHINES
Device Classification Name: separator, automated, blood cell and plasma, therapeutic
Regulation Number:
Classification Product Code: LKN
Date Received: 03/29/1983
Decision Date: 09/12/1983
Regulation Medical Specialty:
Device Name: AUTOMATED 8400 BLOOD CELL SEPARATOR
Manufacturer: INTL. BUSINESS MACHINES
Device Classification Name: separator, automated, blood cell and plasma, therapeutic
Regulation Number:
Classification Product Code: LKN
Date Received: 03/29/1983
Decision Date: 09/12/1983
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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