WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354


Device Classification Name

u.v. method, cpk isoenzymes

510(k) Number K023744
Device Name WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
Original Applicant
WIENER LABORATORIES S.A.I.C.
2944 riobamba
rosario, 

AR

2000

Original Contact viviana cetola
Regulation Number 862.1215
Classification Product Code
JHW  
Date Received 11/07/2002
Decision Date 01/03/2003
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