510(k) K860753 ยท JWY Manual Antimicrobial Susceptibility Test Systems
SENSITITRE SUSCEPTIBILITY PLATES
| Applicant | Gibco Laboratories Life Technologies, Inc., Andover MA, US |
| Decision | Substantially Equivalent, May 6, 1986 |
| Received | Feb 27, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860753
| 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 |
| Sep 30, 2009 | Trek Diagnostic Systems Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA.
In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Str Terminated |
JTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.