PREMIER HB9210 HBA1C ANALYZER


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K112015
Device Name PREMIER HB9210 HBA1C ANALYZER
Applicant
PRIMUS CORPORATION DBA TRINITY BIOTECH
4231 e. 75th terrace
kansas city, 
MO 
64132

Applicant Contact britt einspahr
Correspondent
PRIMUS CORPORATION DBA TRINITY BIOTECH
4231 e. 75th terrace
kansas city, 
MO 
64132

Correspodent Contact britt einspahr
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 07/13/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No