ROCHE-CREACTIVE PROTEIN (LATEX)


Device Classification Name

system, test, c-reactive protein

510(k) Number K073277
Device Name ROCHE-CREACTIVE PROTEIN (LATEX)
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact kerwin l kaufman
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact kerwin l kaufman
Regulation Number 866.5270
Classification Product Code
DCN  
Date Received 11/21/2007
Decision Date 03/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No