510(k) K853694 ยท KEM Agent, Clearing
XYLENE SUBSTITUTE
| Applicant | Lerner Laboratories, Inc., New Haven CT, US |
| Decision | Substantially Equivalent, Oct 22, 1985 |
| Received | Sep 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853694
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.