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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 BK860034
Tradename Sodium Chloride 1.3%
Device Name Blood Bank Supplies
Original Applicant
Reagent Laboratory, Inc.
300 east ottawa avenue
louisville,  KY  40209
Regulation Number864.9050
Classification Product Code
KSS  
Date Received04/08/1987
Decision Date 06/01/1987
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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