510(k) K011068 ยท KTL Anti-Dna Indirect Immunofluorescent Solid Phase
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
| Applicant | Rhigene, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Apr 11, 2002 |
| Received | Apr 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011068
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.