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FDA 510(k), K111822, STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
FDA 510(k), K111822, STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
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510(K) Number: K111822
Device Name: STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
Manufacturer: DIAGNOSTICA STAGO, INC.
Device Classification Name: Assay, Heparin
Regulation Number: 864.7525
Classification Product Code: KFF
Date Received: 06/28/2011
Decision Date: 10/26/2011
Regulation Medical Specialty: Hematology
Device Name: STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
Manufacturer: DIAGNOSTICA STAGO, INC.
Device Classification Name: Assay, Heparin
Regulation Number: 864.7525
Classification Product Code: KFF
Date Received: 06/28/2011
Decision Date: 10/26/2011
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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