NRBC-CHEX FOR ADVIA


Device Classification Name

control, red-cell

510(k) Number K080016
Device Name NRBC-CHEX FOR ADVIA
Applicant
Streck
7002 south 109th st.
omaha, 
NE 
68128

Applicant Contact erin johnson
Correspondent
Streck
7002 south 109th st.
omaha, 
NE 
68128

Correspodent Contact erin johnson
Regulation Number 864.8625
Classification Product Code
GJR  
Date Received 01/03/2008
Decision Date 02/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No