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FDA 510(k)

EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT

K-Number: K072249 · 2008-02-20

ApplicantMedica Corp.
Decision Date2008-02-20
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT 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 2008-02-20 under 510(k) number K072249. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT?

EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT is a medical device that received FDA 510(k) clearance on 2008-02-20. The listed applicant is Medica Corp.. The 510(k) number is K072249.

When did EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT receive FDA 510(k) clearance?

EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT received FDA 510(k) clearance on 2008-02-20, under 510(k) number K072249.

Who is the listed applicant for EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT 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 CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT?

The FDA product code for EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT is CHH.

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Other records listing Medica Corp. as applicant

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K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALK111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALK112788EASTLYTE NA/K/CA/PHK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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