510(k) K141757 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
ALERE I STREP A
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Mar 31, 2015 |
| Received | Jun 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141757
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.