ATAC CALCIUM REAGENT AND ATAC CALIBRATOR


Device Classification Name

cresolphthalein complexone, calcium

510(k) Number K023105
Device Name ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
Original Applicant
ELAN DIAGNOSTICS
1075 w. lambert rd., suite d
brea, 
CA 
92821

Original Contact wynn stocking
Regulation Number 862.1145
Classification Product Code
CIC  
Date Received 09/18/2002
Decision Date 03/13/2003
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