IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR


Device Classification Name

ige, antigen, antiserum, control

510(k) Number K024210
Device Name IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
Original Applicant
BECKMAN COULTER, INC.
200 south kraemer blvd. w-110
brea, 
CA 
92822

Original Contact annette hellie
Regulation Number 866.5510
Classification Product Code
DGC  
Date Received 12/20/2002
Decision Date 02/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No