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FDA 510(k)

DATAPRO CLINICAL CHELISTRY ANALYZER

K-Number: K042767 · 2005-04-27

ApplicantThermo Electron Corporation
Decision Date2005-04-27
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATAPRO CLINICAL CHELISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Electron Corporation. It received FDA 510(k) clearance on 2005-04-27 under 510(k) number K042767. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATAPRO CLINICAL CHELISTRY ANALYZER?

DATAPRO CLINICAL CHELISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Thermo Electron Corporation. The 510(k) number is K042767.

When did DATAPRO CLINICAL CHELISTRY ANALYZER receive FDA 510(k) clearance?

DATAPRO CLINICAL CHELISTRY ANALYZER received FDA 510(k) clearance on 2005-04-27, under 510(k) number K042767.

Who is the listed applicant for DATAPRO CLINICAL CHELISTRY ANALYZER?

The FDA 510(k) record lists Thermo Electron Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATAPRO CLINICAL CHELISTRY ANALYZER?

The FDA product code for DATAPRO CLINICAL CHELISTRY ANALYZER is CFR.

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Other records listing Thermo Electron Corporation 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.

K041657THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT

Related Devices (Code: CFR)

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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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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