FDA 510(k) Applications Submitted by VALYNDA L MACHEN
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K042651 |
09/28/2004 |
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K033603 |
11/17/2003 |
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 |
BECKMAN COULTER, INC. |
K061190 |
04/28/2006 |
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 |
BECKMAN COULTER, INC. |
K061382 |
05/18/2006 |
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 |
BECKMAN COULTER, INC. |
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