510(k) K972220 ยท DHR System, Test, Rheumatoid Factor
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Sep 9, 1997 |
| Received | Jun 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972220
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2019 | Randox Laboratories Ltd. Rheumatoid Factor Standard (RF CAL)
Catalogue Number: RF2301
GTIN: 05055273205039
Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic rea Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.