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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen Mailer And Storage, Sterile
510(k) Number K862665
Device Name NOVACYTE-U
Applicant
Xsirius Medical, Inc.
Peninsula Pt.e Suite 260
27520 Hawthorne Blvd.
Rolling Hills Estates,  CA  90274
Applicant Contact ERIC LIETZ
Correspondent
Xsirius Medical, Inc.
Peninsula Pt.e Suite 260
27520 Hawthorne Blvd.
Rolling Hills Estates,  CA  90274
Correspondent Contact ERIC LIETZ
Regulation Number864.3250
Classification Product Code
KDT  
Date Received07/14/1986
Decision Date 09/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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