Device Classification Name ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
510(k) Number K014018
Device Name CHOLESTEROL 1, 2, 3
Applicant
IMI
16809 BRIARDALE RD.
ROCKVILLE,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
IMI
16809 BRIARDALE RD.
ROCKVILLE,  MD  20855
Correspondent Contact THOMAS M TSAKERIS
Regulation Number862.1475
Classification Product Code
LBS  
Date Received12/06/2001
Decision Date 06/24/2002
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No