SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR


Device Classification Name

system, test, c-reactive protein

510(k) Number K021572
Device Name SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
Original Applicant
BECKMAN COULTER, INC.
200 south kraemer blvd. w-110
brea, 
CA 
92822

Original Contact mary beth tang
Regulation Number 866.5270
Classification Product Code
DCN  
Subsequent Product Code
JIS  
Date Received 05/14/2002
Decision Date 07/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No