FDA 510(k)

EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT

K-Number: K080874 · 2009-02-20

Decision Date2009-02-20

Product CodeCIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K080874. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT?

EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Medica Corp.. The 510(k) number is K080874.

When did EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT receive FDA 510(k) clearance?

EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT received FDA 510(k) clearance on 2009-02-20, under 510(k) number K080874.

Who is the listed applicant for EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT?

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

What is the FDA product code for EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT?

The FDA product code for EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT is CIX.

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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.