FDA 510(k) Application Details - K013783

Device Classification Name Automated Urinalysis System

  More FDA Info for this Device
510(K) Number K013783
Device Name Automated Urinalysis System
Applicant INTERNATIONAL REMOTE IMAGING SYSTEMS
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact CYNTHIA J.M NOLTE
Other 510(k) Applications for this Contact
Regulation Number 862.2900

  More FDA Info for this Regulation Number
Classification Product Code KQO
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/14/2001
Decision Date 01/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact