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510(k) K964151

BARD AND BTA TEST by Bard Diagnostic Sciences,Inc. — Product Code MMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1997
Date Received
October 1, 1996
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 Bard Diagnostic Sciences,Inc.

  • K974845 — BTA STAT TEST PRESCRIPTION HOME USE (December 8, 1998)
  • K971402 — BARD BTA TRAK TEST (April 15, 1998)

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  • K021231 — NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT (July 30, 2002)
  • K013785 — UROVYSION BLADDER CANCER RECURRENCE KIT (February 8, 2002)
  • K011031 — VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT (August 3, 2001)
  • K974845 — BTA STAT TEST PRESCRIPTION HOME USE (December 8, 1998)
  • K971402 — BARD BTA TRAK TEST (April 15, 1998)
  • K970353 — AURA TEK FDP (April 30, 1997)