510(k) K182582 ยท SCL Allergen And Vaccine Delivery Needles
Oryum and Ovem Epidermal Deri Prick Test Applicator
| Applicant | Allergy & Applicator Depot, LLC, Sound Beach NY, US |
| Decision | Substantially Equivalent, Apr 10, 2019 |
| Received | Sep 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182582
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.