CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB

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 Cliniqa Liquid Qc Lipid Control Levels 1 & 2;linical Lipid Calibration Verifiers Levels A-e For Olympus Au Systems;qalib.

Pre-market Notification Details

Device IDK061182
510k NumberK061182
Device Name:CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB
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 Received2006-04-27
Decision Date2006-05-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817238010295 K061182 000
00817238010271 K061182 000
00857969006433 K061182 000

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