510(k) K943812 ยท LSR Reagent, Borrelia Serological Reagent
VIDAS LYME SCREEN II
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Jun 13, 1995 |
| Received | Aug 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Biomerieux, Inc. VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml Terminated |
LSR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.