COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160


Device Classification Name

lipoprotein, low-density, antigen, antiserum, control

510(k) Number K122722
Device Name COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact lisa k klinedinst
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact lisa k klinedinst
Regulation Number 866.5600
Classification Product Code
DFC  
Subsequent Product Codes
JIT   JJX  
Date Received 09/05/2012
Decision Date 11/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No