The following data is part of a premarket notification filed by Intersep Ltd. with the FDA for Nanosep N10.
| Device ID | K935496 |
| 510k Number | K935496 |
| Device Name: | NANOSEP N10 |
| Classification | Clinical Sample Concentrator |
| Applicant | INTERSEP LTD. CRANE HOUSE, MOLLY MILLARS LANE BERKSHIRE RG11 2RZ, England, GB |
| Contact | Richard Hicks |
| Correspondent | Richard Hicks INTERSEP LTD. CRANE HOUSE, MOLLY MILLARS LANE BERKSHIRE RG11 2RZ, England, GB |
| Product Code | JJH |
| CFR Regulation Number | 862.2310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-15 |
| Decision Date | 1994-04-26 |