510(k) K984631 ยท LSL Dna-Reagents, Neisseria
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
| Applicant | Becton Dickinson Microbiology Systems, Sparks MD, US |
| Decision | Substantially Equivalent, Nov 4, 1999 |
| Received | Dec 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2011 | Becton Dickinson & Co. BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***
The BD ProbeTec" ET Chlamydia trachomatis and Neisseria go Terminated |
MKZ | None listed |
| Aug 20, 2003 | Becton Dickinson & Co. Becton Dickinson's ProbeTec (tm) ET Instrument Terminated |
LSL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.