510(k) K862453 ยท JIS Calibrator, Primary
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Aug 19, 1986 |
| Received | Jun 27, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862453
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.