CDS HEMATOLOGY CALIBRATOR (CDS CAL)

Calibrator For Hemoglobin And Hematocrit Measurement

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Clinical Diagnostic Solutions, Inc. with the FDA for Cds Hematology Calibrator (cds Cal).

Pre-market Notification Details

Device IDK041130
510k NumberK041130
Device Name:CDS HEMATOLOGY CALIBRATOR (CDS CAL)
ClassificationCalibrator For Hemoglobin And Hematocrit Measurement
Applicant CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation,  FL  33313
ContactAndrew Swanson
CorrespondentAndrew Swanson
CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation,  FL  33313
Product CodeKRZ  
Subsequent Product CodeKRY
Subsequent Product CodeKSA
CFR Regulation Number864.8165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-30
Decision Date2004-06-10

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