510(k) K043067 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
| Applicant | Bioarray Solutions, Ltd., Warren NJ, US |
| Decision | Substantially Equivalent, May 31, 2005 |
| Received | Nov 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043067
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.