SPIFE LD-12 KIT, MODEL 3338


Device Classification Name

electrophoretic, lactate dehydrogenase isoenzymes

510(k) Number K022455
Device Name SPIFE LD-12 KIT, MODEL 3338
Original Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Original Contact patricia franks
Regulation Number 862.1445
Classification Product Code
CFE  
Date Received 07/26/2002
Decision Date 10/01/2002
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