The following data is part of a premarket notification filed by Genprime, Inc with the FDA for Genprime Snap-top Split Key Cup.
| Device ID | K140665 |
| 510k Number | K140665 |
| Device Name: | GenPrime Snap-Top Split Key Cup |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | GENPRIME, INC 502 W. Riversude, Suite 101 Spokane, WA 99201 |
| Contact | Darby Mclean |
| Correspondent | Maureen Garner NEW WORLD REGULATORY SOLUTIONS, INC. 1983 HAZELWOOD ROAD Toms River, NJ 08753 |
| Product Code | DIS |
| Subsequent Product Code | DIO |
| Subsequent Product Code | JXM |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-12-08 |
| Summary: | summary |