LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE

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 4 Calibration Verifiers Levels-a-e For Beckman Coulter Immage.

Pre-market Notification Details

Device IDK022885
510k NumberK022885
Device Name:LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE
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 Received2002-08-30
Decision Date2002-10-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817238010691 K022885 000

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