CELL-DYN 22 PLUS CALIBRATOR


Device Classification Name

calibrator for cell indices

510(k) Number K111204
Device Name CELL-DYN 22 PLUS CALIBRATOR
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 864.8150
Classification Product Code
KRX  
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