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FDA 510(k)

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS

K-Number: K040927 · 2004-05-17

ApplicantCliniqa Corporation
Decision Date2004-05-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Cliniqa Corporation. It received FDA 510(k) clearance on 2004-05-17 under 510(k) number K040927. 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 PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS?

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Cliniqa Corporation. The 510(k) number is K040927.

When did LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS receive FDA 510(k) clearance?

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS received FDA 510(k) clearance on 2004-05-17, under 510(k) number K040927.

Who is the listed applicant for LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS?

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 PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS?

The FDA product code for LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS 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)

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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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