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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 K871342
Device Name QM2/QM300 CONTROL A PACK
Applicant
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact JAN PETERSEN
Correspondent
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact JAN PETERSEN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/02/1987
Decision Date 05/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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