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FDA 510(k)

EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER

K-Number: K063376 · 2007-06-25

ApplicantMedica Corp.
Decision Date2007-06-25
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL 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 2007-06-25 under 510(k) number K063376. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER?

EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER is a medical device that received FDA 510(k) clearance on 2007-06-25. The listed applicant is Medica Corp.. The 510(k) number is K063376.

When did EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER receive FDA 510(k) clearance?

EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER received FDA 510(k) clearance on 2007-06-25, under 510(k) number K063376.

Who is the listed applicant for EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL 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 EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER?

The FDA product code for EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER is CHL.

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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: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ 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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