510(k) K974370 ยท DHR System, Test, Rheumatoid Factor
RAPET RF
| Applicant | Stanbio Laboratory, San Antonio TX, US |
| Decision | Substantially Equivalent, Feb 17, 1998 |
| Received | Nov 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2018 | Stanbio Laboratory, LP RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30)
RF Latex (1156-001, Control# 172224 expiry 2019-12-31)
RF Latex (1155L-100B, Co Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.