PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100


the company

Device Classification Name

immunoelectrophoretic, immunoglobulins, (g, a, m)

510(k) Number K002799
Device Name PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
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
CFF  
Date Received 09/08/2000
Decision Date 10/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

Type Special
Reviewed by Third Party No

Combination Product

No