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FDA 510(k)

THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT

K-Number: K041657 · 2004-08-30

ApplicantThermo Electron Corporation
Decision Date2004-08-30
Product CodeKQN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT 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 2004-08-30 under 510(k) number K041657. The device is classified under product code KQN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT?

THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT is a medical device that received FDA 510(k) clearance on 2004-08-30. The listed applicant is Thermo Electron Corporation. The 510(k) number is K041657.

When did THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT receive FDA 510(k) clearance?

THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT received FDA 510(k) clearance on 2004-08-30, under 510(k) number K041657.

Who is the listed applicant for THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT?

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 THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT?

The FDA product code for THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT is KQN.

Related Clinical Trials

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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.

K042767DATAPRO CLINICAL CHELISTRY ANALYZER

Related Devices (Code: KQN)

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.

K942497ANGIOTENSIN CONVERTING ENZYME REAAmerican Laboratory Products Co., Ltd.K913091BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAYAmerican Laboratory Products Co., Ltd.K854876ALDOSTERONE DIRECT RIA KITBiotecx Laboratories, Inc.K854245SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVSigma Diagnostics, Inc.K833933ACE COLOR TESTHana Biologics, Inc.K821011ACE ACTIVITY MICROVIAL TEST SETVentrex Laboratories, Inc.

Official Source

View on FDA Database →

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

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