510(k) K100728 ยท LSR Reagent, Borrelia Serological Reagent
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jul 6, 2010 |
| Received | Mar 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100728
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.