ATAC PAK ALBUMIN REAGENT


Device Classification Name

bromcresol green dye-binding, albumin

510(k) Number K030006
Device Name ATAC PAK ALBUMIN REAGENT
Original Applicant
ELAN DIAGNOSTICS
1075 w. lambert rd., suite d
brea, 
CA 
92821

Original Contact wynn stocking
Regulation Number 862.1035
Classification Product Code
CIX  
Date Received 01/02/2003
Decision Date 03/07/2003
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