510(k) K080812 ยท KHE Reagent, Occult Blood
HEMOCCULT ICT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 25, 2008 |
| Received | Mar 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2013 | Assuramed Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mi Terminated |
KHE | None listed |
| Aug 22, 2013 | Beckman Coulter Inc. Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.