510(k) K912888 ยท MIG Strip, Test Isoniazid
URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
| Applicant | Dynagen, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Feb 24, 1992 |
| Received | Jul 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912888
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.