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510(k) K021231

NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT by Matritech, Inc. — Product Code MMW

K021231 is an FDA 510(k) premarket notification submitted by Matritech, Inc. for the device "NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT". The FDA issued a decision of Substantially Equivalent on July 30, 2002. The device falls under product code MMW (System, Test, Tumor Marker, Monitoring, Bladder), a Class II device regulated under 21 CFR 866.6010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2002
Date Received
April 18, 2002
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

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  • 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)
  • K964151 — BARD AND BTA TEST (April 16, 1997)

FDA data resources