510(k) K855238 ยท JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
BIOTEL (TM)/UTI
| Applicant | American Diagnostic Corp., Wheaton IL, US |
| Decision | Substantially Equivalent, May 9, 1986 |
| Received | Dec 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855238
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.