Precision Systems Analette Chemistry Analyzer

FDA 510(k) K013654 · Precision Systems, Inc.

Substantially Equivalent

510(k) numberK013654

Submission

Device name
Precision Systems Analette Chemistry Analyzer
Applicant
Precision Systems, Inc.
Natick, MA, US
Received
November 6, 2001
Decision date
June 5, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JJF – Analyzer, Chemistry, Micro, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2170
Specialty
Clinical Chemistry

Other 510(k)s with product code JJF

510(k)DeviceApplicantDecision
K052794Eti-Max 3000JJF · Traditional DiaSorin, Inc.03/31/2006SE
K040332Polymedco Spotchem Ez Chemistry AnalyzerJJF · Traditional Arkray, Inc.06/16/2004SE
K033734Lightcycler Instrument Version 1.2JJF · Traditional Roche Diagnostics Corp.12/17/2003SE
K012966Roche Cobas Taqman AnalyzerJJF · Traditional Roche Molecular Systems, Inc.02/01/2002SE
K993634Careside AnalyzerJJF · Traditional Careside, Inc.12/02/1999SE
K973628Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional Vital Scientific N.V.03/13/1998SE
K980056Careside AnalyzerJJF · Traditional Exigent Diagnostics, Inc.03/06/1998SE
K973177Mago Automated Eia ProcessorJJF · Traditional Diamedix Corp.10/09/1997SE
K971491Synermed Ir 200 Chemistry AnalyzerJJF · Traditional Synermed, Inc.06/26/1997SE
K964506Roche Cobas Amplicor AnalyzerJJF · Traditional Roche Molecular Systems, Inc.05/21/1997SE

More from Roche Molecular Systems, Inc.

510(k)DeviceDecision
K024182Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsCDQ · Traditional 03/03/2003SE
K022072Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems ReagentsCIX · Traditional 08/23/2002SE

Questions and answers

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

Precision Systems Analette Chemistry Analyzer (K013654) received a 510(k) decision of Substantially Equivalent on June 5, 2002, 211 days after the submission was received.

What is the product code of K013654?

The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.