Uric Acid Test Kit

FDA 510(k) K901001 · Elite Technology, Inc.

Substantially Equivalent

510(k) numberK901001

Submission

Device name
Uric Acid Test Kit
Applicant
Elite Technology, Inc.
Canada M9w 5p1, CA
Received
March 2, 1990
Decision date
May 23, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNK – Acid, Uric, Uricase (Colorimetric)
Device class
Class I (low risk)
Regulation
21 CFR 862.1775
Specialty
Clinical Chemistry

Other 510(k)s with product code KNK

510(k)DeviceApplicantDecision
K102568Uric Acid Model 3P39KNK · Traditional Abbott Laboratories05/06/2011SE
K062862Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional Olympus America, Inc.04/06/2007SE
K040467Vitalab Uric Acid ReagentKNK · Traditional Clinical Data, Inc.03/08/2004SE
K031044Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional Clinical Data, Inc.07/15/2003SE
K022096Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional Bayer Diagnostics Corp.03/18/2003SE
K023550Wiener Lab Uricostat Enzimatico Aa LiquidaKNK · Traditional Wiener Laboratories Saic12/09/2002SE
K012038Jas Uric Acid Liquid ReagentKNK · Traditional Jas Diagnostics, Inc.08/21/2001SE
K010421Wiener Lab. Uricostat Enzimatico Aa, Models 2X50 ML Catalogue No 1840106 and 4X50 ML…KNK · Traditional Wiener Laboratories Saic04/13/2001SE
K993469Wako L-Type Ua F TestKNK · Traditional Wako Chemicals USA, Inc.11/09/1999SE
K991247Uric Acid, Model UA112-01KNK · Traditional A.P. Total Care, Inc.05/25/1999SE

More from A.P. Total Care, Inc.

510(k)DeviceDecision
K900733Protein Test for Urine and CSFCEK · Traditional 07/10/1990SE
K901090Elitech Gamma GT Test KitJPZ · Traditional 03/29/1990SE
K895951Cholesterol Test KitCHH · Traditional 02/16/1990SE
K895952Triglycerides Test KitCDT · Traditional 01/11/1990SE

Questions and answers

When was Uric Acid Test Kit cleared by the FDA?

Uric Acid Test Kit (K901001) received a 510(k) decision of Substantially Equivalent on May 23, 1990, 82 days after the submission was received.

What is the product code of K901001?

The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.