Data / Medical devices / United States / Allergy & Applicator Depot, LLC
Allergy & Applicator Depot, LLC: FDA-registered device maker in Manorville, NY, United States, 1 510(k) clearance
Allergy & Applicator Depot, LLC is registered with the FDA (registration 3015536286) in Manorville, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015536286
- Address
- 150 Silas Carter Road, Manorville, NY, United States, 11949
- Owner or operator
- Allergy & Applicator Depot, LLC (10060801)
- Roles
- Specification developer
- First device listed
- June 25, 2019
- Registered through
- 2026
- Brand names listed
- Oryum and Ovem Epidermal Skin Prick Test Applicator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Allergen And Vaccine Delivery Needles | SCL | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2019 | K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | SCL | Substantially Equivalent | Allergy & Applicator Depot, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 10, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.