Data / Medical devices / United States / Mawi Dna Technologies
Mawi Dna Technologies: FDA-registered device maker in Pleasanton, CA, United States, 1 510(k) clearance
Mawi Dna Technologies is registered with the FDA (registration 3013373509) in Pleasanton, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013373509
- Address
- 1252 Quarry Lane, Suite A, Pleasanton, CA, United States, 94566
- Owner or operator
- Mawi DNA Technologies (10076840)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 20, 2023
- Registered through
- 2026
- Brand names listed
- iSWAB-RC-EL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| April 3, 2023 | K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) | QBD | Substantially Equivalent | Mawi Dna Technologies | accessdata.fda.gov |
Compare with other makers
Updated April 3, 2023. 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.