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FDA 510(k)

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY

K-Number: K913091 · 1991-08-26

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date1991-08-26
Product CodeKQN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY 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 1991-08-26 under 510(k) number K913091. 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 BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY?

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K913091.

When did BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY receive FDA 510(k) clearance?

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY received FDA 510(k) clearance on 1991-08-26, under 510(k) number K913091.

Who is the listed applicant for BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY?

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 BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY?

The FDA product code for BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY is KQN.

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

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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 CorporationK942497ANGIOTENSIN CONVERTING ENZYME REAAmerican 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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