SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR


codes

Device Classification Name

calibrator, primary

510(k) Number K000331
Device Name SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
Original Applicant
BECKMAN COULTER, INC.
200 s. kraemer blvd.,m/s w-104
box 8000
brea, 
CA 
92822 -8000

Original Contact gail lefebvre
Regulation Number 862.1150
Classification Product Code
JIS  
Date Received 12/22/1999
Decision Date 02/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No