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FDA 510(k)

HIGH METABOLITE QUALICHECK

K-Number: K130415 · 2013-03-26

ApplicantRadiometer Medical Aps
Decision Date2013-03-26
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HIGH METABOLITE QUALICHECK is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2013-03-26 under 510(k) number K130415. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH METABOLITE QUALICHECK?

HIGH METABOLITE QUALICHECK is a medical device that received FDA 510(k) clearance on 2013-03-26. The listed applicant is Radiometer Medical Aps. The 510(k) number is K130415.

When did HIGH METABOLITE QUALICHECK receive FDA 510(k) clearance?

HIGH METABOLITE QUALICHECK received FDA 510(k) clearance on 2013-03-26, under 510(k) number K130415.

Who is the listed applicant for HIGH METABOLITE QUALICHECK?

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

What is the FDA product code for HIGH METABOLITE QUALICHECK?

The FDA product code for HIGH METABOLITE QUALICHECK is JJS.

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Other records listing Radiometer Medical Aps as applicant

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K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXK170882ABL90 FLEX, ABL90 FLEX PLUSK160153ABL90 FLEX PLUSK131988ABL90 FLEX ANALYZERK130144ABL90 FLEXK123748ABL90 FLEX

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Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-RadK003242LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623Bio-Rad

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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