510(k) K091653 ยท ORI Levetiracetam Assay
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
| Applicant | Ark Diagnostics, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 2, 2009 |
| Received | Jun 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091653
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.