FDA 510(k) Applications Submitted by JAN OLSEN
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K000196 |
01/21/2000 |
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 |
BECKMAN COULTER, INC. |
K002453 |
08/10/2000 |
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 |
BECKMAN COULTER, INC. |
K963934 |
10/01/1996 |
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 |
BIO-RAD LABORATORIES, INC. |
K974075 |
10/29/1997 |
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
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