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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 K863503
Device Name HEMOLYSE
Applicant
Reagent Laboratory, Inc.
300 E. Ottawa Ave.
Louisville,  KY  40209
Applicant Contact DONALD SKAGGS
Correspondent
Reagent Laboratory, Inc.
300 E. Ottawa Ave.
Louisville,  KY  40209
Correspondent Contact DONALD SKAGGS
Regulation Number864.8540
Classification Product Code
GGK  
Date Received09/09/1986
Decision Date 10/03/1986
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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