FDA 510(k), K003301, DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

FDA 510(k), K003301, DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

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510(K) Number: K003301
Device Name: DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
Manufacturer: CELLAVISION AB
Device Classification Name: device, automated cell-locating
Regulation Number: 864.5260
Classification Product Code: JOY
Date Received: 10/20/2000
Decision Date: 03/15/2001
Regulation Medical Specialty: Hematology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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