510(k) K842828 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
STREPTEX ZL01
| Applicant | Wellcome Diagnostics, Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 15, 1984 |
| Received | Jul 20, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2013 | Remel Inc Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label Terminated |
JTO | None listed |
| Dec 18, 2013 | Remel Inc Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartfor Terminated |
JTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.