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FDA 510(k)

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER

K-Number: K013654 · 2002-06-05

ApplicantPrecision Systems, Inc.
Decision Date2002-06-05
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Precision Systems, Inc.. It received FDA 510(k) clearance on 2002-06-05 under 510(k) number K013654. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER?

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2002-06-05. The listed applicant is Precision Systems, Inc.. The 510(k) number is K013654.

When did PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER receive FDA 510(k) clearance?

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER received FDA 510(k) clearance on 2002-06-05, under 510(k) number K013654.

Who is the listed applicant for PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER?

The FDA 510(k) record lists Precision Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER?

The FDA product code for PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER is JJF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Precision Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K024182PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTSK022072PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS

Related Devices (Code: JJF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, Inc.K973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAVital Scientific N.V.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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