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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