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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Herpes Simplex Virus Nucleic Acid Amplification Assay
510(k) Number K111951
Device Name ISOAMP HSV ASSAY
Applicant
Biohelix Corporation
32 Tozer Rd.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Biohelix Corporation
32 Tozer Rd.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.3305
Classification Product Code
OQO  
Date Received07/08/2011
Decision Date 09/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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