510(k) K970373 ยท DHR System, Test, Rheumatoid Factor
RAICHEM RHEUMATOID FACTOR SPIA
| Applicant | Henage Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 17, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970373
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.