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

Single (specified) Analyte Controls (assayed And Unassayed)

CLINIQA CORPORATION

The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Uric Acid Calibration Verifiers Levels A - E For Olympus Au Systems.

Pre-market Notification Details

Device IDK040455
510k NumberK040455
Device Name:LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook,  CA  92028
ContactCarol Ruggiero
CorrespondentCarol Ruggiero
CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook,  CA  92028
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-23
Decision Date2004-03-05

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