510(k) K953345 ยท JQW Station, Pipetting And Diluting, For Clinical Use
GENESIS
| Applicant | Tecan U.S., Inc., Research Triangle Park NC, US |
| Decision | Substantially Equivalent, Nov 21, 1995 |
| Received | Jul 12, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Roche Diagnostics Corp. Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. Terminated |
JQW | None listed |
| Jul 20, 2004 | Tecan U S Inc Tecan Clinical Workstations with Robonet software Terminated |
JQW | None listed |
| May 29, 2003 | Tecan U S Inc Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower. Terminated |
JQW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.