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FDA 510(k)

ANGIOTENSIN CONVERTING ENZYME ASSAY SYS

K-Number: K791712 · 1979-09-19

ApplicantVentrex Laboratories, Inc.
Decision Date1979-09-19
Product CodeKQN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANGIOTENSIN CONVERTING ENZYME ASSAY SYS is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1979-09-19 under 510(k) number K791712. 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 ASSAY SYS?

ANGIOTENSIN CONVERTING ENZYME ASSAY SYS is a medical device that received FDA 510(k) clearance on 1979-09-19. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K791712.

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

ANGIOTENSIN CONVERTING ENZYME ASSAY SYS received FDA 510(k) clearance on 1979-09-19, under 510(k) number K791712.

Who is the listed applicant for ANGIOTENSIN CONVERTING ENZYME ASSAY SYS?

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

What is the FDA product code for ANGIOTENSIN CONVERTING ENZYME ASSAY SYS?

The FDA product code for ANGIOTENSIN CONVERTING ENZYME ASSAY SYS is KQN.

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Other records listing Ventrex Laboratories, 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.

K914554SPECIFIC IGE EIA-TURBO ASSAYK913833VENTREX ALLERGEN DISCK913434VENTREX COATED TUBE INTACT PTHK905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA KIT

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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.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.

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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