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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name blood establishment computer software and accessories
510(k) Number BK010025
Tradename Chiron Procleix NAT Tracker 1.0E
Original Applicant
Chiron Corporation
4560 horton street
emeryville,  CA  94608 US
Current 510(k) Holder
No 510(k) holder with active listings
No 510(k) contact with active listings identified
Regulation Number864.9165
Classification Product Code
Date Received07/23/2001
Decision Date 01/03/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No