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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 K904968
Device Name QCLYTE PROTEIN BASED ISE CONTROL
Applicant
Baxter Healthcare Corp
35 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact CONNIE HERTEL
Correspondent
Baxter Healthcare Corp
35 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact CONNIE HERTEL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/05/1990
Decision Date 12/06/1990
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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