CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

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 Unassayed And Assayed General Chemistry Control Levels 1, 2, & 3.

Pre-market Notification Details

Device IDK070741
510k NumberK070741
Device Name:CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
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 Received2007-03-16
Decision Date2007-05-04

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