ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)


Device Classification Name

photometric method, iron (non-heme)

510(k) Number K030528
Device Name ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
Applicant
CLINICAL DATA
1075 w. lambert rd., suite d
brea, 
CA 
92821

Applicant Contact wynn stocking
Correspondent
CLINICAL DATA
1075 w. lambert rd., suite d
brea, 
CA 
92821

Correspodent Contact wynn stocking
Regulation Number 862.1410
Classification Product Code
JIY  
Subsequent Product Code
JMO  
Date Received 02/19/2003
Decision Date 06/17/2003
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