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FDA 510(k), K031377, SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
FDA 510(k), K031377, SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
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510(K) Number: K031377
Device Name: SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
Manufacturer: DADE BEHRING, INC.
Device Classification Name: instrument, coagulation, automated
Regulation Number: 864.5400
Classification Product Code: GKP
Date Received: 05/01/2003
Decision Date: 09/08/2003
Regulation Medical Specialty: Hematology
Device Name: SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
Manufacturer: DADE BEHRING, INC.
Device Classification Name: instrument, coagulation, automated
Regulation Number: 864.5400
Classification Product Code: GKP
Date Received: 05/01/2003
Decision Date: 09/08/2003
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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