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510(k) K970353

AURA TEK FDP by Perimmune, Inc. — Product Code MMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1997
Date Received
January 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Tumor Marker, Monitoring, Bladder
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Perimmune, Inc.

  • K970302 — APO-TEK LP(A) (November 10, 1997)

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