DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX


Device Classification Name

apolipoproteins

510(k) Number K073488
Device Name DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
Applicant
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Applicant Contact charles yu
Correspondent
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Correspodent Contact charles yu
Regulation Number 862.1475
Classification Product Code
MSJ  
Subsequent Product Codes
JIT   JJX  
Date Received 10/22/2007
Decision Date 03/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No