ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR


Device Classification Name

diazo colorimetry, bilirubin

510(k) Number K030003
Device Name ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
Original Applicant
ELAN DIAGNOSTICS
1075 w. lambert rd., suite d
brea, 
CA 
92821

Original Contact wynn stocking
Regulation Number 862.1110
Classification Product Code
CIG  
Subsequent Product Code
JIS  
Date Received 01/02/2003
Decision Date 09/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No