ADVIA RETIC PLUS


Device Classification Name

mixture, hematology quality control

510(k) Number K010461
Device Name ADVIA RETIC PLUS
Original Applicant
R & D SYSTEMS, INC.
614 mckinley pl., n.e.
minneapolis, 
MN 
55413

Original Contact kenneth t edds
Regulation Number 864.8625
Classification Product Code
JPK  
Date Received 02/16/2001
Decision Date 04/03/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No