N LATEX B2-MICROGLOBULIN


Device Classification Name

system, test, beta-2-microglobulin immunological

510(k) Number K002731
Device Name N LATEX B2-MICROGLOBULIN
Original Applicant
DADE BEHRING, INC.
7739 nw 48 st.
suite 120
miami, 
FL 
33166

Original Contact radames riesgo
Regulation Number 866.5630
Classification Product Code
JZG  
Date Received 09/01/2000
Decision Date 11/20/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No