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FDA 510(k)

EASYRA CREATININE REAGENT

K-Number: K123586 · 2013-05-15

ApplicantMedica Corporation
Decision Date2013-05-15
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYRA CREATININE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corporation. It received FDA 510(k) clearance on 2013-05-15 under 510(k) number K123586. 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 EASYRA CREATININE REAGENT?

EASYRA CREATININE REAGENT is a medical device that received FDA 510(k) clearance on 2013-05-15. The listed applicant is Medica Corporation. The 510(k) number is K123586.

When did EASYRA CREATININE REAGENT receive FDA 510(k) clearance?

EASYRA CREATININE REAGENT received FDA 510(k) clearance on 2013-05-15, under 510(k) number K123586.

Who is the listed applicant for EASYRA CREATININE REAGENT?

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

What is the FDA product code for EASYRA CREATININE REAGENT?

The FDA product code for EASYRA CREATININE REAGENT is CGX.

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Other records listing Medica Corporation 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.

K220328EasyStat 300K220396EasyStat 300K211559EasyStat 300K152327EasyLyte Na/K/Cl/Ca AnalyzerK111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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