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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name procalcitonin assay
510(k) Number K170652
Device Name ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
Applicant
Fisher Diagnostics
8365 Valley Pike
Middletown,  VA  22645
Applicant Contact Connie Yang
Correspondent
Precision for Medicine
2 Bethesda Metro Center, Suite 850
Bethesda,  MD  20814
Correspondent Contact Kennon Daniels
Regulation Number866.3215
Classification Product Code
PRI  
Subsequent Product Codes
JIT   JJX   PMT   PTF  
Date Received03/03/2017
Decision Date 06/01/2017
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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