510(k) K060322 ยท JIT Calibrator, Secondary
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
| Applicant | Cliniqa Corporation, Fallbrook CA, US |
| Decision | Substantially Equivalent, Mar 21, 2006 |
| Received | Feb 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA. Terminated |
NAY | None listed |
| Feb 21, 2008 | Intuitive Surgical, Inc. Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086. Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.