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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K871033
Device Name RABBIT KIDNEY CULTURE CELLS (FIRST PASS)
Applicant
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact LORRAINE WEAVER
Correspondent
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact LORRAINE WEAVER
Regulation Number864.2280
Classification Product Code
KIR  
Date Received03/16/1987
Decision Date 03/31/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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