CDS 3-PD HEMATOLOGY CONTROLS


Device Classification Name

mixture, hematology quality control

510(k) Number K024173
Device Name CDS 3-PD HEMATOLOGY CONTROLS
Original Applicant
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1660 n.w. 65th ave., suite 2
plantation, 
FL 
33313

Original Contact andrew c swanson
Regulation Number 864.8625
Classification Product Code
JPK  
Date Received 12/18/2002
Decision Date 01/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls