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510(k) K974845

BTA STAT TEST PRESCRIPTION HOME USE by Bard Diagnostic Sciences,Inc. — Product Code MMW

K974845 is an FDA 510(k) premarket notification submitted by Bard Diagnostic Sciences,Inc. for the device "BTA STAT TEST PRESCRIPTION HOME USE". The FDA issued a decision of Substantially Equivalent on December 8, 1998. 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
December 8, 1998
Date Received
December 18, 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 Bard Diagnostic Sciences,Inc.

  • K971402 — BARD BTA TRAK TEST (April 15, 1998)
  • K964151 — BARD AND BTA TEST (April 16, 1997)

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)
  • K971402 — BARD BTA TRAK TEST (April 15, 1998)
  • K970353 — AURA TEK FDP (April 30, 1997)
  • K964151 — BARD AND BTA TEST (April 16, 1997)

FDA data resources