VITALAB IRON REAGENT

Device Classification Name

photometric method, iron (non-heme)

510(k) Number K033983
Device Name VITALAB IRON REAGENT
Applicant
CLINICAL DATA, INC.
1075 w. lambert road
suite d
brea, 
CA 
92821

Applicant Contact wynn stocking
Regulation Number 862.1410
Classification Product Code
JIY  
Date Received 12/23/2003
Decision Date 05/21/2004
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 Yes

Combination Product

No