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FDA 510(k), K973050, MICRO21 WITH WBC ESTIMATE
FDA 510(k), K973050, MICRO21 WITH WBC ESTIMATE
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510(K) Number: K973050
Device Name: MICRO21 WITH WBC ESTIMATE
Manufacturer: TRIANGLE BIOMEDICAL SCIENCES, INC.
Device Classification Name: device, automated cell-locating
Regulation Number: 864.5260
Classification Product Code: JOY
Date Received: 08/15/1997
Decision Date: 11/07/1997
Regulation Medical Specialty: Hematology
Device Name: MICRO21 WITH WBC ESTIMATE
Manufacturer: TRIANGLE BIOMEDICAL SCIENCES, INC.
Device Classification Name: device, automated cell-locating
Regulation Number: 864.5260
Classification Product Code: JOY
Date Received: 08/15/1997
Decision Date: 11/07/1997
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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