WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311

Phosphomolybdate (colorimetric), Inorganic Phosphorus

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.fosfatemia Uv, Models 1x100 Ml Cat.n 1382321, 4x20 Ml Cat.n 1009311.

Pre-market Notification Details

• Device ID: K013095
• 510k Number: K013095
• Device Name: WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
• Classification: Phosphomolybdate (colorimetric), Inorganic Phosphorus
• 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: CEO
• CFR Regulation Number: 862.1580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-17
• Decision Date: 2001-11-16
• Summary: summary