510(k) K993850 ยท JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
| Applicant | International Newtech Development, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Jan 3, 2000 |
| Received | Nov 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993850
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 Open, Classified |
JMT | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 Open, Classified |
JMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.