ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS


Device Classification Name

myoglobin, antigen, antiserum, control

510(k) Number K080481
Device Name ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

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

Correspodent Contact chechamma varughese
Regulation Number 866.5680
Classification Product Code
DDR  
Subsequent Product Code
JIT  
Date Received 02/22/2008
Decision Date 02/20/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No