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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Leukocyte Typing
510(k) Number K894947
Device Name PLATELIA TOXO IGG KIT
Applicant
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
2000 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Applicant Contact SUSAN TESMER
Correspondent
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
2000 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Correspondent Contact SUSAN TESMER
Regulation Number864.7675
Classification Product Code
LGO  
Date Received08/03/1989
Decision Date 03/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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