IQ 200 SYSTEM


Device Classification Name

counter, urine particle

510(k) Number K022774
Device Name IQ 200 SYSTEM
Original Applicant
INTL. REMOTE IMAGING SYSTEMS
9162 eton ave.
chatsworth, 
CA 
91311

Original Contact harvey l kasdan
Regulation Number 864.5200
Classification Product Code
LKM  
Subsequent Product Code
KQO  
Date Received 08/21/2002
Decision Date 10/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No