510(k) K110619 ยท MRG System, Test, Vitamin D
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
| Applicant | Biokit, S.A., Llissa D'Amunt, Barcelona, ES |
| Decision | Substantially Equivalent, Nov 23, 2011 |
| Received | Mar 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110619
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2013 | Abbott Laboratories Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic. Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.