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510(k) K964151

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

K964151 is an FDA 510(k) premarket notification submitted by Bard Diagnostic Sciences,Inc. for the device "BARD AND BTA TEST". The FDA issued a decision of Substantially Equivalent on April 16, 1997. The device falls under product code MMW (System, Test, Tumor Marker, Monitoring, Bladder), a Class II device regulated under 21 CFR 866.6010. Bard Diagnostic Sciences,Inc. has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code MMW

  • K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX (May 4, 2023)
  • K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST (January 22, 2004)
  • 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)

FDA data resources