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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rotavirus
510(k) Number K853554
Device Name PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
Applicant
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact KATIA BRESLAWEC
Correspondent
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact KATIA BRESLAWEC
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received08/26/1985
Decision Date 11/26/1985
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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