HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134


Device Classification Name

electrophoretic separation, lipoproteins

510(k) Number K022053
Device Name HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
Original Applicant
SEBIA
13805 waterloo
chelsea, 
MI 
48118

Original Contact borek janik
Regulation Number 862.1475
Classification Product Code
JHO  
Date Received 06/24/2002
Decision Date 07/12/2002
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

Category: Uncategorized