510(k) K983244 ยท JTW System, Transport, Aerobic
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
| Applicant | Trek Diagnostic Systems, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 30, 1998 |
| Received | Sep 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983244
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST Terminated |
JWY | None listed |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.