ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345


Device Classification Name

immunoassay method, troponin subunit

510(k) Number K021814
Device Name ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Original Contact brent taber
Regulation Number 862.1215
Classification Product Code
MMI  
Date Received 06/03/2002
Decision Date 09/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls