510(k) K981555 ยท LJX Test, Urine Leukocyte
DIASCREEN REAGENT STRIPS
| Applicant | Chronimed, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Jun 1, 1998 |
| Received | May 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2010 | ARKRAY USA INC. Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400. Terminated |
LJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.