Ua(Uricase) Reagent

FDA 510(k) K852004 · Alpkem Corp.

Substantially Equivalent

510(k) numberK852004

Submission

Device name
Ua(Uricase) Reagent
Applicant
Alpkem Corp.
Clackamas, OR, US
Received
May 7, 1985
Decision date
May 29, 1985
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

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K890337Triglycerides - Gpo ReagentCDT · Traditional 03/09/1989SE
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K890333Albumin ReagentEIX · Traditional 02/17/1989SE
K890332RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional 02/17/1989SE
K883020RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional 09/02/1988SE
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Questions and answers

When was Ua(Uricase) Reagent cleared by the FDA?

Ua(Uricase) Reagent (K852004) received a 510(k) decision of Substantially Equivalent on May 29, 1985, 22 days after the submission was received.

What is the product code of K852004?

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