MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES

Calibrator, Multi-analyte Mixture

VERICHEM LABORATORIES, INC.

The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Multi-chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard Kit, Choles.

Pre-market Notification Details

• Device ID: K112834
• 510k Number: K112834
• Device Name: MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
• Classification: Calibrator, Multi-analyte Mixture
• Applicant: VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907
• Contact: Anthony James Dimonte
• Correspondent: Anthony James Dimonte; VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907
• Product Code: JIX
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-28
• Decision Date: 2012-03-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00852553007360	K112834	000
00852553007278	K112834	000
00852553007254	K112834	000
00852553007179	K112834	000
00852553007162	K112834	000
00852553007100	K112834	000
00852553007094	K112834	000
00852553007032	K112834	000