FDA 510(k) Applications Submitted by VALYNDA 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.


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