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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name products, red-cell lysing products
510(k) Number DK812002
Tradename ELUAID System for Antibody Elution
Device Name Red Cell Lysing Reagent
Original Applicant
Ortho-Clinical Diagnostics, Inc.
1001 u.s. highway 202
p.o. box 350
raritan,  NJ  08869 0606
Regulation Number864.8540
Classification Product Code
GGK  
Date Received10/08/1981
Decision Date 10/28/1981
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 No
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