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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Automated Blood Cell Diluting
510(k) Number K904795
Device Name FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number864.5240
Classification Product Code
GKH  
Date Received10/19/1990
Decision Date 12/31/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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