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510(k) K862665

NOVACYTE-U by Xsirius Medical, Inc. — Product Code KDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1986
Date Received
July 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
Submission Type

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