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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K882082
Device Name QM300 ALBUMIN ANTIBODY PACK
Applicant
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
2000 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Applicant Contact JAN OLSEN
Correspondent
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
2000 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Correspondent Contact JAN OLSEN
Regulation Number866.5040
Classification Product Code
DCF  
Date Received05/18/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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