510(k) K122398 ยท JIX Calibrator, Multi-Analyte Mixture
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
| Applicant | Siemens Healthcare Diagnostics, Inc., Norowood MA, US |
| Decision | Substantially Equivalent, Oct 12, 2012 |
| Received | Aug 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood.
SMN: 10844813 Open, Classified |
JIX | None listed |
| Dec 21, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood.
SMN: 10491447 Open, Classified |
JIX | None listed |
| Dec 21, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood.
SMN: 10491448 Open, Classified |
JIX | None listed |
| Dec 21, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood.
SMN: 10491449 Open, Classified |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.