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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 media, potentiating for in vitro diagnostic use
510(k) Number BK860016
Tradename PENTEX MOD-U-CYTE II & VIII
Device Name Media, Potentiating for In Vitro Diagnostic Use
Original Applicant
Miles, Inc.
4th and parker streets, p.o. box 1986
berkeley,  CA  94701 1986
Regulation Number864.9600
Classification Product Code
KSG  
Date Received04/01/1986
Decision Date 04/17/1987
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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