Data / Medical devices / United States / Sixarp LLC, Praxis
Sixarp LLC, Praxis: FDA-registered device maker in Grand Rapids, MI, United States, 2 510(k) clearances
Sixarp LLC, Praxis is registered with the FDA (registration 1000115322) in Grand Rapids, MI, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000115322
- Address
- 7650 Caterpillar Ct SW Ste D, Grand Rapids, MI, United States, 49548
- Owner or operator
- Sixarp LLC, Praxis (10031872)
- Roles
- Repackager or relabeler
- First device listed
- December 9, 2011
- Registered through
- 2026
- Brand names listed
- AgaMatrix, BinaxNOW COVID-19 Antigen Card Self Test, Good Clean Love Personal Lubricant, Almost Naked Hint of Mint; Good Clean Love Personal Lubricant, Guilty Pleasure; Good
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | N | Repackager or relabeler | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| November 19, 2015 | K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla | NUC | Substantially Equivalent | Good Clean Love, Inc. | accessdata.fda.gov |
| September 27, 2007 | K072413 | MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Agamatrix | accessdata.fda.gov |
Compare with other makers
- All makers of Coronavirus Antigen Detection Test System.
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Pad, Alcohol, Device Disinfectant
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
Updated November 19, 2015. 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.