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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 K863114
Device Name PIASTRINIT
Applicant
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Applicant Contact DI PIETRO
Correspondent
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Correspondent Contact DI PIETRO
Regulation Number864.8540
Classification Product Code
GGK  
Date Received08/13/1986
Decision Date 11/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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