LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS

Multi-analyte Controls, All Kinds (assayed)

CLINIQA CORPORATION

The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Protein 2 Calibration Verifiers Levels A-e For Olympus Au Analyzers.

Pre-market Notification Details

Device IDK031575
510k NumberK031575
Device Name:LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook,  CA  92028
ContactCarol Ruggiero
CorrespondentCarol Ruggiero
CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook,  CA  92028
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-20
Decision Date2003-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817238010745 K031575 000
00817238010660 K031575 000

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