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FDA 510(k), K071132, G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
FDA 510(k), K071132, G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
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510(K) Number: K071132
Device Name: G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
Manufacturer: Tosoh BioScience, Inc.
Device Classification Name: assay, glycosylated hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 04/23/2007
Decision Date: 09/16/2008
Regulation Medical Specialty: Hematology
Device Name: G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
Manufacturer: Tosoh BioScience, Inc.
Device Classification Name: assay, glycosylated hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 04/23/2007
Decision Date: 09/16/2008
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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