510(k) K831469 ยท JSK Supplement, Culture Media
LEGIONELLA CYE AGAR BASE & BCYE SUPPL
| Applicant | Oxoid U.S.A., Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jun 8, 1983 |
| Received | May 6, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2015 | Remel Inc Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstok Terminated |
JSK | None listed |
| Dec 12, 2014 | Remel Inc Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials.
A growth supplement for the isolation of Legionella. Terminated |
JSK | None listed |
| Nov 10, 2014 | Remel Inc Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg.
A growth supplement for the isolation of Legionella. Terminated |
JSK | None listed |
| Feb 26, 2014 | Remel Inc Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England.
The product is use Terminated |
JSK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.