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

U.v. Method, Cpk Isoenzymes

WIENER LABORATORIES S.A.I.C.

The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Ck-mb Ds Uv Unitest, Model 28 X 2.5 Ml Cat. Nr. 1271354.

Pre-market Notification Details

• Device ID: K023744
• 510k Number: K023744
• Device Name: WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
• Classification: U.v. Method, Cpk Isoenzymes
• Applicant: WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000
• Contact: Viviana Cetola
• Correspondent: Viviana Cetola; WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000
• Product Code: JHW
• CFR Regulation Number: 862.1215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-11-07
• Decision Date: 2003-01-03