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FDA 510(k)

FLOW-PAC CREATININE REAGENT SET

K-Number: K830537 · 1983-03-24

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

Device Summary

FLOW-PAC CREATININE 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 K830537. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW-PAC CREATININE REAGENT SET?

FLOW-PAC CREATININE 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 K830537.

When did FLOW-PAC CREATININE REAGENT SET receive FDA 510(k) clearance?

FLOW-PAC CREATININE REAGENT SET received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830537.

Who is the listed applicant for FLOW-PAC CREATININE 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 FLOW-PAC CREATININE REAGENT SET?

The FDA product code for FLOW-PAC CREATININE REAGENT SET is CGX.

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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: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare 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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