RAICHEM LDL-CHOLESTEROL DIRECT REAGENT


Device Classification Name

system, test, low density, lipoprotein

510(k) Number K022772
Device Name RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
Original Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 red branch rd.
columbia, 
MD 
21045

Original Contact jose a montanez
Regulation Number 862.1475
Classification Product Code
MRR  
Date Received 08/21/2002
Decision Date 09/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No