510(k) K053037 ยท DJG Enzyme Immunoassay, Opiates
ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
| Applicant | Acro Biotech, LLC, Rancho Cucamonga CA, US |
| Decision | Substantially Equivalent, Jun 15, 2006 |
| Received | Oct 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053037
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.