510(k) K041297 ยท KHE Reagent, Occult Blood
POLYMEDCO OC LIGHT FOBT TEST
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Aug 12, 2004 |
| Received | May 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2013 | Polymedco, Inc Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50.
For the rapid, qualitative detection of human hemoglobin in feces. Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.