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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K911885
Device Name DADE(R) PROTEIN C ABNORMAL CONTRAL
Applicant
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Applicant Contact NANCY A HORNBAKER
Correspondent
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Correspondent Contact NANCY A HORNBAKER
Regulation Number864.5425
Classification Product Code
GGC  
Date Received04/29/1991
Decision Date 06/11/1991
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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