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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K881503
Device Name MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
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 Number862.1660
Classification Product Code
JJY  
Date Received04/11/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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