510(k) K924061 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CANCER ANTIGEN CONTROL
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Feb 23, 1993 |
| Received | Aug 12, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2025 | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor
FOBT (Fecal Occult Blood Test) Open, Classified |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.