Data / Medical devices / United States / Bpi Labs, Inc.
Bpi Labs, Inc.: FDA-registered device maker in Evanston, WY, United States, 1 510(k) clearance
Bpi Labs, Inc. is registered with the FDA (registration 3008875046) in Evanston, WY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 6, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008875046
- Address
- 97 S Red Willow Rd, Evanston, WY, United States, 82930
- Owner or operator
- BPI Labs, Inc. DBA Ally Labs (10051731)
- Roles
- Manufacturer
- First device listed
- December 29, 2016
- Registered through
- 2026
- Brand names listed
- Hello Sailor Lube, Lulu Lube, Nooky Lube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 6, 2016 | K161585 | Mano and Mano Personal Lubricant | NUC | Substantially Equivalent | Mano and Mano Proprietary Limited | accessdata.fda.gov |
Compare with other makers
Updated September 6, 2016. 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.