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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K852125
Device Name PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
Applicant
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact DIANA SALDITT
Correspondent
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact DIANA SALDITT
Regulation Number866.3305
Classification Product Code
GQL  
Date Received05/15/1985
Decision Date 07/30/1985
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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