COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B


Device Classification Name

electrode measurement, blood-gases (pco2, po2) and blood ph

510(k) Number K111188
Device Name COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
Applicant
Roche Diagnostics
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact sarah baumann
Correspondent
Roche Diagnostics
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact sarah baumann
Regulation Number 862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   GGZ   GHS   GKA  
GKF   GLY   JFP   JGS   JJY   KHG  
KHP  
Date Received 04/27/2011
Decision Date 05/14/2012
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

Recalls CDRH Recalls