FDA 510(k)

EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT

K-Number: K080810 · 2008-12-10

Decision Date2008-12-10

Product CodeCIG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM 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 2008-12-10 under 510(k) number K080810. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT?

EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT is a medical device that received FDA 510(k) clearance on 2008-12-10. The listed applicant is Medica Corp.. The 510(k) number is K080810.

When did EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT receive FDA 510(k) clearance?

EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT received FDA 510(k) clearance on 2008-12-10, under 510(k) number K080810.

Who is the listed applicant for EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM 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 BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT?

The FDA product code for EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT is CIG.

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Other records listing Medica Corp. as applicant

K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT K120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL K112788EASTLYTE NA/K/CA/PH K101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

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Related Devices (Code: CIG)

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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.