510(k) K001356 ยท DJC Thin Layer Chromatography, Methamphetamine
ONTRAK TESTCUP PRO-5, MODEL 1986678
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 10, 2000 |
| Received | Apr 28, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001356
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.