510(k) K921855 ยท JIS Calibrator, Primary
BIOTROL BICARBONATE STANDARDS
| Applicant | Biotrol, USA, Inc., Exton PA, US |
| Decision | Substantially Equivalent, Aug 3, 1992 |
| Received | Apr 17, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921855
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.