510(k) K911400 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
WALKAWAY TM 40
| Applicant | Baxter Healthcare Corp, West Sacramento CA, US |
| Decision | Substantially Equivalent, Nov 19, 1991 |
| Received | Mar 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2019 | Beckman Coulter Inc. MicroScan WalkAway-40 plus Instrument REF B1018-283 Open, Classified |
LRG | None listed |
| Oct 21, 2019 | Beckman Coulter Inc. MicroScan WalkAway-96 plus Instrument REF B1018-284 Open, Classified |
LRG | None listed |
| Oct 21, 2019 | Beckman Coulter Inc. DxM 1040 MicroScan WalkAway Instrument REF B1018-440 Open, Classified |
LRG | None listed |
| Oct 21, 2019 | Beckman Coulter Inc. DxM 1096 MicroScan WalkAway Instrument REF B1018-496 Open, Classified |
LRG | None listed |
| Oct 21, 2019 | Beckman Coulter Inc. MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R Open, Classified |
LRG | None listed |
| Oct 21, 2019 | Beckman Coulter Inc. MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R Open, Classified |
LRG | None listed |
| Sep 4, 2019 | Beckman Coulter Inc. MicroScan WalkAway-40 plus Instrument Terminated |
LRG | None listed |
| Sep 4, 2019 | Beckman Coulter Inc. MicroScan WalkAway-96 plus Instrument Terminated |
LRG | None listed |
| Sep 4, 2019 | Beckman Coulter Inc. MicroScan WalkAway-40 plus Reconditioned Instrument Terminated |
LRG | None listed |
| Sep 4, 2019 | Beckman Coulter Inc. MicroScan WalkAway-96 plus Reconditioned Instrument Terminated |
LRG | None listed |
| Jul 2, 2014 | Siemens Healthcare Diagnostics, Inc. MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge.
Siemens Healthcare Diagnostics, Inc.
in vitro diagnostic Terminated |
LRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.