510(k) K945271 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM
| Applicant | Bio-Chem Laboratory Systems, Inc., Lakewood NJ, US |
| Decision | Substantially Equivalent, Apr 20, 1995 |
| Received | Oct 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945271
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2017 | ELITech Clinical Systems SAS ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x
20 mL Calibrator Low level). Model/Catalog Number: 55117 Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.