WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K024280
Device Name WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
Original Applicant
WAKO CHEMICALS, USA, INC.
1600 bellwood road
richmond, 
VA 
23237

Original Contact tonya mallory
Regulation Number 866.5270
Classification Product Code
DCK  
Subsequent Product Codes
JIT   JJK  
Date Received 12/23/2002
Decision Date 06/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No