Data / Medical devices / United States / Analysis Oasis Global LLC
Analysis Oasis Global LLC: FDA-registered device maker in Newark, DE, United States, 2 510(k) clearances
Analysis Oasis Global LLC is registered with the FDA (registration 3042271096) in Newark, DE, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042271096
- Address
- 254 Chapman Rd Ste 208 #24748, Newark, DE, United States, 19702
- Owner or operator
- ANALYSIS OASIS GLOBAL LLC (10094422)
- Roles
- Repackager or relabeler
- First device listed
- April 28, 2026
- Registered through
- 2026
- Brand names listed
- Analysis Oasis Marijuana(THC) Urine Test Dip Card, Analysis Oasis Marijuana(THC) Urine Test Strip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Test, Cannabinoid, Over The Counter | NFW | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 16, 2019 | K191924 | SAFECARE® THC Urine Strip Test | NFW | Substantially Equivalent | Safecare Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| March 18, 2016 | K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana | DIO | Substantially Equivalent | Safecare Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Cannabinoid, Over The Counter
- All makers of Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- All makers of Enzyme Immunoassay, Cannabinoids
- All makers of Enzyme Immunoassay, Amphetamine
Updated August 16, 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.