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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K875165
Device Name QM300 LAMBDA LIGHT CHAINS 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 Number866.5550
Classification Product Code
DEH  
Date Received12/16/1987
Decision Date 01/22/1988
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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