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FDA 510(k), K990449, HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
FDA 510(k), K990449, HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
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510(K) Number: K990449
Device Name: HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 02/12/1999
Decision Date: 04/13/1999
Regulation Medical Specialty: Hematology
Device Name: HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 02/12/1999
Decision Date: 04/13/1999
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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