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FDA 510(k), K062925, COAGUCHEK XS SYSTEM
FDA 510(k), K062925, COAGUCHEK XS SYSTEM
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510(K) Number: K062925
Device Name: COAGUCHEK XS SYSTEM
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: Test, Time, Prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 09/28/2006
Decision Date: 01/29/2007
Regulation Medical Specialty: Hematology
Device Name: COAGUCHEK XS SYSTEM
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: Test, Time, Prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 09/28/2006
Decision Date: 01/29/2007
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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