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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name instrument, hematocrit, automated
510(k) Number BK050056
Tradenames UltraChek Reference Controls - Product Code GLK, UltraCritTM Hematocrit Measurement Device - Product Code GKF
Device Name Instrument, Hematocrit, Automated
Original Applicant
Separation Technology, Inc.
1096 rainier drive
altamonte springs,  FL  32714 3855
Regulation Number864.5600
Classification Product Code
GKF  
Date Received09/29/2005
Decision Date 12/12/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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