RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER


Device Classification Name

ldl & vldl precipitation, hdl

510(k) Number K023784
Device Name RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
Original Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 red branch rd.
columbia, 
MD 
21045

Original Contact jose a montanez
Regulation Number 862.1475
Classification Product Code
LBR  
Date Received 11/12/2002
Decision Date 12/24/2002
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