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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, Herpes Simplex Virus, Non-Specific
510(k) Number K802526
Device Name TEST KIT FOR DETECTION OF HERPES SIMPLEX
Applicant
Bartels & Stout, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bartels & Stout, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3305
Classification Product Code
LGC  
Date Received10/15/1980
Decision Date 02/09/1981
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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