CDS 3-PD HEMATOLOGY CONTROLS

Mixture, Hematology Quality Control

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Clinical Diagnostic Solutions, Inc. with the FDA for Cds 3-pd Hematology Controls.

Pre-market Notification Details

Device IDK024173
510k NumberK024173
Device Name:CDS 3-PD HEMATOLOGY CONTROLS
ClassificationMixture, Hematology Quality Control
Applicant CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation,  FL  33313
ContactAndrew C Swanson
CorrespondentAndrew C Swanson
CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation,  FL  33313
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-18
Decision Date2003-01-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.