DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K110188
Device Name DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
Applicant
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Applicant Contact abhijit datta
Correspondent
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Correspodent Contact abhijit datta
Regulation Number 864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received 01/24/2011
Decision Date 05/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No