510(k) K041202 ยท KHE Reagent, Occult Blood
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
| Applicant | W.H.P.M., Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Aug 12, 2004 |
| Received | May 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2019 | Cypress Medical Products LLC McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50,
178CK30 Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.