UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K121492
Device Name UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd
a2.sw.09
brea, 
CA 
92822

Applicant Contact annette hellie
Correspondent
BECKMAN COULTER, INC.
250 south kraemer blvd
a2.sw.09
brea, 
CA 
92822

Correspodent Contact annette hellie
Regulation Number 864.7470
Classification Product Code
LCP  
Subsequent Product Code
KRZ  
Date Received 05/21/2012
Decision Date 09/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No