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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K910885
Device Name QM300 CALIBRATOR G PACK
Applicant
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact JAN NEBELSICK
Correspondent
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact JAN NEBELSICK
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received03/04/1991
Decision Date 06/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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