Data / Medical devices / United States / Usa Scientific, Inc.
Usa Scientific, Inc.: FDA-registered device maker in Ocala, FL, United States, 1 510(k) clearance
Usa Scientific, Inc. is registered with the FDA (registration 3012748721) in Ocala, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 29, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012748721
- Address
- 346 SW 57TH Ave, Ocala, FL, United States, 34474
- Owner or operator
- USA Scientific (10055595)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 1, 2024
- Registered through
- 2026
- Brand names listed
- Layer4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| November 29, 2010 | K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated November 29, 2010. 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.