510(k) K123274 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
PROGASTRO SSCS ASSAY
| Applicant | Gen-Probe Prodesse, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 16, 2013 |
| Received | Oct 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123274
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.