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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K981278
Device Name ELECSYS CALCHECK CA 125II
Applicant
Roche Diagnostics GmbH
4300 Hacienda Dr.
Pleasanton,  CA  94566 -0900
Applicant Contact Patricia M Klimley
Correspondent
Roche Diagnostics GmbH
4300 Hacienda Dr.
Pleasanton,  CA  94566 -0900
Correspondent Contact Patricia M Klimley
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/08/1998
Decision Date 04/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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