SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE


Device Classification Name

mixture, hematology quality control

510(k) Number K991876
Device Name SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
Applicant
R & D SYSTEMS, INC.
614 mckinley pl., n.e.
minneapolis, 
MN 
55413

Applicant Contact sue gallo
Correspondent
R & D SYSTEMS, INC.
614 mckinley pl., n.e.
minneapolis, 
MN 
55413

Correspodent Contact sue gallo
Regulation Number 864.8625
Classification Product Code
JPK  
Date Received 06/02/1999
Decision Date 06/17/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No