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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact