SPIFE LIPPOROTEIN-12, MODEL 3344


Device Classification Name

electrophoretic separation, lipoproteins

510(k) Number K022333
Device Name SPIFE LIPPOROTEIN-12, MODEL 3344
Original Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Original Contact patricia franks
Regulation Number 862.1475
Classification Product Code
JHO  
Date Received 07/18/2002
Decision Date 08/15/2002
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