510(k) K102314 ยท OOI Real Time Nucleic Acid Amplification System
3M INTEGRATED CYCLER (110V) & (220V)
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Oct 29, 2010 |
| Received | Aug 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102314
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.