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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K884901
Device Name DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
Applicant
Baxter Healthcare Corp
P.O.Box 520672
Miami,  FL  33152
Applicant Contact JEANNE-MARIE VARGA
Correspondent
Baxter Healthcare Corp
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact JEANNE-MARIE VARGA
Regulation Number864.5425
Classification Product Code
GGN  
Date Received11/23/1988
Decision Date 02/02/1989
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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