ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647


Device Classification Name

system, test, immunological, antigen, tumor

510(k) Number K072612
Device Name ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Applicant Contact rachelle parsons
Correspondent
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Correspodent Contact rachelle parsons
Regulation Number 866.6010
Classification Product Code
MOI  
Subsequent Product Code
JIT  
Date Received 09/17/2007
Decision Date 10/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No