Cleared Traditional

NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT

K021231 · Matritech, Inc. · Immunology

Jul 2002

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K021231 is an FDA 510(k) clearance for the NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT, a System, Test, Tumor Marker, Monitoring, Bladder (Class II — Special Controls, product code MMW), submitted by Matritech, Inc. (Newton, US). The FDA issued a Cleared decision on July 30, 2002, 103 days after receiving the submission on April 18, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K021231 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2002
Decision Date	July 30, 2002
Days to Decision	103 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF