NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT


Device Classification Name

system, test, tumor marker, monitoring, bladder

510(k) Number K021231
Device Name NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
Original Applicant
MATRITECH, INC.
330 nevada st., 2nd fl.
newton, 
MA 
02460

Original Contact melodie r domurad
Regulation Number 866.6010
Classification Product Code
MMW  
Date Received 04/18/2002
Decision Date 07/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No