AUTION JET AJ-4270 URINE ANALYZER


Device Classification Name

automated urinalysis system

510(k) Number K030600
Device Name AUTION JET AJ-4270 URINE ANALYZER
Applicant
INTERNATIONAL REMOTE IMAGING SYSTEMS
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact cynthia j.m. nolte
Correspondent
INTERNATIONAL REMOTE IMAGING SYSTEMS
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact cynthia j.m. nolte
Regulation Number 862.2900
Classification Product Code
KQO  
Subsequent Product Codes
JIL   JIO  
Date Received 02/25/2003
Decision Date 07/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No