510(k) K801665 ยท JIS Calibrator, Primary
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
| Applicant | Miles Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 20, 1980 |
| Received | Jul 21, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801665
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.