Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents

FDA 510(k) K024182 · Precision Systems, Inc.

Substantially Equivalent

510(k) numberK024182

Submission

Device name
Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents
Applicant
Precision Systems, Inc.
Natick, MA, US
Received
December 19, 2002
Decision date
March 3, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1770
Specialty
Clinical Chemistry

Other 510(k)s with product code CDQ

510(k)DeviceApplicantDecision
K203771Urea Nitrogen2CDQ · Traditional Abbott Ireland Diagnostics Division05/31/2022SE
K140690BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerCDQ · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.09/02/2014SE
K110675Easyra Urea Nitrogen and Creatinine ReagentsCDQ · Traditional Medica Corp.04/21/2011SE
K073295Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional Thermofisher Scientific OY05/29/2008SE
K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPCDQ · Traditional Horiba Abx10/12/2007SE
K060120Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional Teco Diagnostics03/27/2006SE
K041051Raichem Bun Rate Reagent (Liquid)CDQ · Traditional Hemagen Diagnostics, Inc.06/30/2004SE
K021385Atac Pak Bun ReagentCDQ · Traditional Elan Diagnostics07/12/2002SE
K012649Raichem Bun Rate ReagentCDQ · Traditional Hemagen Diagnostics, Inc.10/15/2001SE
K012260Wiener Lab. Urea UV Cinetica AaCDQ · Traditional Wiener Laboratories Saic09/19/2001SE

More from Wiener Laboratories Saic

510(k)DeviceDecision
K022072Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems ReagentsCIX · Traditional 08/23/2002SE
K013654Precision Systems Analette Chemistry AnalyzerJJF · Traditional 06/05/2002SE

Questions and answers

When was Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents cleared by the FDA?

Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents (K024182) received a 510(k) decision of Substantially Equivalent on March 3, 2003, 74 days after the submission was received.

What is the product code of K024182?

The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.