510(k) K133303 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
| Applicant | Bio-Analysis, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Nov 19, 2014 |
| Received | Oct 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133303
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.