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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name 21-hydroxylase antibody (21-ohab)
510(k) Number K121046
Device Name STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
Original Applicant
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
170 s. seneca springs way
suite 105
star,  ID  83669
Original Contact heather viele
Regulation Number866.5660
Classification Product Code
PCG  
Date Received04/06/2012
Decision Date 12/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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