FDA 510(k) Applications Submitted by LYNN S WEIST
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K080634 |
03/06/2008 |
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 |
BECKMAN COULTER, INC. |
K020881 |
03/18/2002 |
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT |
SCIENCE INCORPORATED |
K031269 |
04/21/2003 |
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K031270 |
04/21/2003 |
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K031297 |
04/24/2003 |
ACCESS OV MONITOR ASSAY |
BECKMAN COULTER, INC. |
K031506 |
05/14/2003 |
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY |
BECKMAN COULTER, INC. |
K031606 |
05/22/2003 |
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY |
BECKMAN COULTER, INC. |
K032162 |
07/15/2003 |
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY |
BECKMAN COULTER, INC. |
K052223 |
08/15/2005 |
ACCESS EPO ASSAY |
BECKMAN COULTER, INC. |
K023764 |
11/12/2002 |
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 |
BECKMAN COULTER, INC. |
K010824 |
03/19/2001 |
PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT |
SCIENCE INCORPORATED |
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