Uric Acid Procedure

FDA 510(k) K861660 · Data Medical Associates, Inc.

Substantially Equivalent

510(k) numberK861660

Submission

Device name
Uric Acid Procedure
Applicant
Data Medical Associates, Inc.
Arlington, TX, US
Received
April 30, 1986
Decision date
June 13, 1986
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
K993098Hdl-C/Ldl-C Calibrator, Model 1913-003JIX · Traditional 10/08/1999SE
K971113Dma Triglycerides ProceduresCDT · Traditional 05/29/1997SE
K961919Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional 07/01/1996SE
K955796Iron Calibrator & Calibration Verification SetJJX · Traditional 02/29/1996SE
K955302Serum Bicarbonate/Carbon DioxideKHS · Traditional 02/29/1996SE
K955300Total Bilirubin ProcedureCIG · Traditional 12/20/1995SE
K952437Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional 10/03/1995SE
K946161Dma Total Cholesterol ProcedureCHH · Traditional 08/23/1995SE
K946354Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional 05/08/1995SE
K946355Dma Albumin ProcedureCIX · Traditional 03/01/1995SE

Questions and answers

When was Uric Acid Procedure cleared by the FDA?

Uric Acid Procedure (K861660) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 44 days after the submission was received.

What is the product code of K861660?

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