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FDA 510(k), K984188, AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
FDA 510(k), K984188, AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
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510(K) Number: K984188
Device Name: AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
Manufacturer: CHROMAVISION MEDICAL SYSTEMS, INC.
Device Classification Name: device, automated cell-locating
Regulation Number: 864.5260
Classification Product Code: JOY
Date Received: 11/23/1998
Decision Date: 07/28/1999
Regulation Medical Specialty: Hematology
Device Name: AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
Manufacturer: CHROMAVISION MEDICAL SYSTEMS, INC.
Device Classification Name: device, automated cell-locating
Regulation Number: 864.5260
Classification Product Code: JOY
Date Received: 11/23/1998
Decision Date: 07/28/1999
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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