510(k) K101574 ยท OTF Gabapentin Assay
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
| Applicant | Ark Diagnostics, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 23, 2010 |
| Received | Jun 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101574
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.