PAROS CRP


Device Classification Name

system, test, c-reactive protein

510(k) Number K022690
Device Name PAROS CRP
Original Applicant
HORIBA LTD.
34 bunsen dr.
irvine, 
CA 
92618

Original Contact ian giles
Regulation Number 866.5270
Classification Product Code
DCN  
Date Received 08/13/2002
Decision Date 12/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No