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FDA 510(k), K093460, COAGUCHEK XS PRO SYSTEM
FDA 510(k), K093460, COAGUCHEK XS PRO SYSTEM
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510(K) Number: K093460
Device Name: COAGUCHEK XS PRO SYSTEM
Manufacturer: Roche Diagnostics
Device Classification Name: test, time, prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 11/06/2009
Decision Date: 03/18/2010
Regulation Medical Specialty: Hematology
Device Name: COAGUCHEK XS PRO SYSTEM
Manufacturer: Roche Diagnostics
Device Classification Name: test, time, prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 11/06/2009
Decision Date: 03/18/2010
Regulation Medical Specialty: Hematology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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