ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER


the company

Device Classification Name

system,test,thyroglobulin

510(k) Number K002905
Device Name ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
Original Applicant
BECKMAN COULTER, INC.
7330 carroll rd.
p.o. box 269006
san diego, 
CA 
92196

Original Contact mara caler
Regulation Number 866.6010
Classification Product Code
MSW  
Date Received 09/18/2000
Decision Date 10/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls