510(k) K151690 ยท OOI Real Time Nucleic Acid Amplification System
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jul 16, 2015 |
| Received | Jun 23, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151690
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.