510(k) K905396 ยท JIO Blood, Occult, Colorimetric, In Urine
HEMASTIX REAGENT STRIPS
| Applicant | Heraeus Kulzer, Inc., Mishawaka IN, US |
| Decision | Substantially Equivalent, Feb 11, 1991 |
| Received | Nov 30, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905396
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.