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FDA 510(k)

LUQUIZYME TRIGLYCERIDE REAGENT SET

K-Number: K803297 · 1981-01-16

ApplicantAmresco, Inc.
Decision Date1981-01-16
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUQUIZYME TRIGLYCERIDE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803297. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUQUIZYME TRIGLYCERIDE REAGENT SET?

LUQUIZYME TRIGLYCERIDE REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Amresco, Inc.. The 510(k) number is K803297.

When did LUQUIZYME TRIGLYCERIDE REAGENT SET receive FDA 510(k) clearance?

LUQUIZYME TRIGLYCERIDE REAGENT SET received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803297.

Who is the listed applicant for LUQUIZYME TRIGLYCERIDE REAGENT SET?

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

What is the FDA product code for LUQUIZYME TRIGLYCERIDE REAGENT SET?

The FDA product code for LUQUIZYME TRIGLYCERIDE REAGENT SET is CDT.

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Other records listing Amresco, 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.

K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

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Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, 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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