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FDA 510(k)

LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS

K-Number: K040455 · 2004-03-05

ApplicantCliniqa Corporation
Decision Date2004-03-05
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Cliniqa Corporation. It received FDA 510(k) clearance on 2004-03-05 under 510(k) number K040455. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS?

LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Cliniqa Corporation. The 510(k) number is K040455.

When did LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS receive FDA 510(k) clearance?

LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS received FDA 510(k) clearance on 2004-03-05, under 510(k) number K040455.

Who is the listed applicant for LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS?

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

What is the FDA product code for LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS?

The FDA product code for LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS is JJX.

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Other records listing Cliniqa Corporation 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.

K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LEK083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC

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Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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