ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033


Device Classification Name

calibrator, secondary

510(k) Number K111952
Device Name ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
ms r-275-b
chaska, 
MN 
55318 -1084

Applicant Contact kerrie s oetter
Correspondent
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
ms r-275-b
chaska, 
MN 
55318 -1084

Correspodent Contact kerrie s oetter
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 07/11/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls