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FDA 510(k)

LIQUILYME BUN REAGENT

K-Number: K812945 · 1981-11-06

ApplicantAmresco, Inc.
Decision Date1981-11-06
Product CodeLFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUILYME BUN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812945. The device is classified under product code LFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUILYME BUN REAGENT?

LIQUILYME BUN REAGENT is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Amresco, Inc.. The 510(k) number is K812945.

When did LIQUILYME BUN REAGENT receive FDA 510(k) clearance?

LIQUILYME BUN REAGENT received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812945.

Who is the listed applicant for LIQUILYME BUN REAGENT?

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 LIQUILYME BUN REAGENT?

The FDA product code for LIQUILYME BUN REAGENT is LFP.

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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: LFP)

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.

K990039GAMBRO DQM 200Gambro HealthcareK992847HICHEM BUN REAGENTElan Holdings, Inc.K963537SIGMA DIAGNOSTICS BUN REAGENTSigma Diagnostics, Inc.K933679SIGMA BUN REAGENTSigma Chemical Co.K873132BUN REAGENT KITA-Kem, 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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