CELL-DYN 22 PLUS CONTROL


Device Classification Name

mixture, control, white-cell and red-cell indices

510(k) Number K111211
Device Name CELL-DYN 22 PLUS CONTROL
Applicant
Streck
7002 south 109th st.
omaha, 
NE 
68128

Applicant Contact deborah kipp
Correspondent
Streck
7002 south 109th st.
omaha, 
NE 
68128

Correspodent Contact deborah kipp
Regulation Number 864.8625
Classification Product Code
GLQ  
Date Received 04/29/2011
Decision Date 12/22/2011
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