CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372


Device Classification Name

fluorometric method, cpk or isoenzymes

510(k) Number K030012
Device Name CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Original Contact brent taber
Regulation Number 862.1215
Classification Product Code
JHX  
Subsequent Product Code
JIS  
Date Received 01/02/2003
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No