MODIFICATION TO RAICHEM CALCIUM REAGENT


Device Classification Name

azo dye, calcium

510(k) Number K022049
Device Name MODIFICATION TO RAICHEM CALCIUM REAGENT
Original Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 red branch rd.
columbia, 
MD 
21045

Original Contact jose a montanez
Regulation Number 862.1145
Classification Product Code
CJY  
Date Received 06/24/2002
Decision Date 07/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No