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FDA 510(k)

AMRESCO UREA NITROGEN REAGENT SET

K-Number: K830555 · 1983-03-24

ApplicantAmresco, Inc.
Decision Date1983-03-24
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO UREA NITROGEN 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 1983-03-24 under 510(k) number K830555. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMRESCO UREA NITROGEN REAGENT SET?

AMRESCO UREA NITROGEN REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Amresco, Inc.. The 510(k) number is K830555.

When did AMRESCO UREA NITROGEN REAGENT SET receive FDA 510(k) clearance?

AMRESCO UREA NITROGEN REAGENT SET received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830555.

Who is the listed applicant for AMRESCO UREA NITROGEN 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 AMRESCO UREA NITROGEN REAGENT SET?

The FDA product code for AMRESCO UREA NITROGEN REAGENT SET is CDQ.

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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: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, 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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