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FDA 510(k), K162540, INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
FDA 510(k), K162540, INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
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510(K) Number: K162540
Device Name: INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
Device Classification Name: Assay, Heparin
Regulation Number: 864.7525
Classification Product Code: KFF
Date Received: 09/12/2016
Decision Date: 08/22/2017
Regulation Medical Specialty: Hematology
Device Name: INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
Device Classification Name: Assay, Heparin
Regulation Number: 864.7525
Classification Product Code: KFF
Date Received: 09/12/2016
Decision Date: 08/22/2017
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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