SPIFE CK KIT, MODEL 3332, 3333


Device Classification Name

colorimetric method, cpk or isoenzymes

510(k) Number K022757
Device Name SPIFE CK KIT, MODEL 3332, 3333
Original Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Original Contact patricia franks
Regulation Number 862.1215
Classification Product Code
JHY  
Date Received 08/20/2002
Decision Date 10/11/2002
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