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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 K974383
Device Name ELECSYS CALCHECK VITAMIN B12
Applicant
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588 -2722
Applicant Contact Patricia M Klimley
Correspondent
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588 -2722
Correspondent Contact Patricia M Klimley
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/21/1997
Decision Date 12/08/1997
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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