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FDA 510(k), K010455, ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
FDA 510(k), K010455, ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
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510(K) Number: K010455
Device Name: ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
Manufacturer: DIAGNOSTICA-STAGO
Device Classification Name: Assay, Heparin
Regulation Number: 864.7525
Classification Product Code: KFF
Date Received: 01/29/2001
Decision Date: 06/07/2001
Regulation Medical Specialty: Hematology
Device Name: ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
Manufacturer: DIAGNOSTICA-STAGO
Device Classification Name: Assay, Heparin
Regulation Number: 864.7525
Classification Product Code: KFF
Date Received: 01/29/2001
Decision Date: 06/07/2001
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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