510(k) K070504 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
AMMONIA/ALCOHOL CONTROL SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Apr 11, 2007 |
| Received | Feb 21, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K070504
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.