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FDA 510(k)

EASYRA CLINICAL CHEMISTRY ANALYZER

K-Number: K070057 · 2007-08-30

ApplicantMedica Corp.
Decision Date2007-08-30
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYRA CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2007-08-30 under 510(k) number K070057. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYRA CLINICAL CHEMISTRY ANALYZER?

EASYRA CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2007-08-30. The listed applicant is Medica Corp.. The 510(k) number is K070057.

When did EASYRA CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

EASYRA CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 2007-08-30, under 510(k) number K070057.

Who is the listed applicant for EASYRA CLINICAL CHEMISTRY ANALYZER?

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 CLINICAL CHEMISTRY ANALYZER?

The FDA product code for EASYRA CLINICAL CHEMISTRY ANALYZER is CGA.

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Other records listing Medica Corp. 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.

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: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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