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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 immunosorbent assay, herpes simplex virus, hsv-1
510(k) Number K143236
Device Name Theranos Herpes Simplex Virus-1 IgG Assay
Applicant
THERANOS, INC.
1701 PAGE MILL ROAD
palo alto,  CA  94304
Applicant Contact brad arington
Correspondent
THERANOS, INC.
1701 PAGE MILL ROAD
palo alto,  CA  94304
Correspondent Contact brad arington
Regulation Number866.3305
Classification Product Code
MXJ  
Date Received11/12/2014
Decision Date 07/02/2015
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
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