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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 K982471
Device Name B2-MICROGLOBULIN CONTROL SET SERUM
Applicant
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact JULIE A SMITH
Correspondent
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact JULIE A SMITH
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/16/1998
Decision Date 08/06/1998
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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