510(k) K173653 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, May 2, 2018 |
| Received | Nov 28, 2017 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K173653
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.