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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK880004
Tradename Buffered Normal Saline Concentrate
Device Name Blood Bank Supplies
Original Applicant
Val Tech Diagnostics
14 werner camp road
pittsburgh,  PA  15238
Regulation Number864.9050
Classification Product Code
KSS  
Date Received02/16/1988
Decision Date 04/11/1988
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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