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FDA 510(k)

ANGIOTENSIN CONVERTING ENZYME REA

K-Number: K942497 · 1994-11-15

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date1994-11-15
Product CodeKQN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANGIOTENSIN CONVERTING ENZYME REA is the device name listed in this FDA 510(k) record. The listed applicant is American Laboratory Products Co., Ltd.. It received FDA 510(k) clearance on 1994-11-15 under 510(k) number K942497. 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 ANGIOTENSIN CONVERTING ENZYME REA?

ANGIOTENSIN CONVERTING ENZYME REA is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K942497.

When did ANGIOTENSIN CONVERTING ENZYME REA receive FDA 510(k) clearance?

ANGIOTENSIN CONVERTING ENZYME REA received FDA 510(k) clearance on 1994-11-15, under 510(k) number K942497.

Who is the listed applicant for ANGIOTENSIN CONVERTING ENZYME REA?

The FDA 510(k) record lists American Laboratory Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANGIOTENSIN CONVERTING ENZYME REA?

The FDA product code for ANGIOTENSIN CONVERTING ENZYME REA is KQN.

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Other records listing American Laboratory Products Co., Ltd. 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.

K012576CIC-C1Q EIAK011415ALPCO MILENIA ANTI-TG EIAK011201ALPCO MILENIA ANTI-TPO ELISAK974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAK974701ORGENTEC ANTI-MPO (P-ANCA) ELISAK972190THYROGLOBULIN ASSAY SYSTEM

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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.

K041657THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENTThermo Electron CorporationK913091BUEHLMANN 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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