510(k) K111999 ยท JIO Blood, Occult, Colorimetric, In Urine
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, Apr 17, 2012 |
| Received | Jul 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111999
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2024 | Healgen Scientific Llc Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color Open, Classified |
JIR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.