Nanosep N10
FDA 510(k) K935496 · Intersep , Ltd.
510(k) numberK935496
Submission
- Device name
- Nanosep N10
- Applicant
- Intersep , Ltd.
England, GB - Received
- November 15, 1993
- Decision date
- April 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJH – Clinical Sample Concentrator
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2310
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113731 | Esensor Respiratory Viral PanelJJH · Traditional | Clinical Micro Sensors, Inc. | 09/10/2012SE |
| K960298 | Vivaspin 4 10,000 MWJJH · Traditional | Vivascience, Inc. | 03/19/1996SE |
| K943966 | Vivapore 2JJH · Traditional | Vivascience, Inc. | 04/11/1995SE |
| K943965 | Vivapore 10JJH · Traditional | Vivascience, Inc. | 04/11/1995SE |
| K941326 | Ultrafree-ClJJH · Traditional | Millipore Corp. | 05/27/1994SE |
| K930168 | Centricon -50 ConcentratorJJH · Traditional | Amicon, Inc. | 08/05/1993SE |
| K893733 | Centricon ConcentratorJJH · Traditional | Amicon, Inc. | 07/20/1989SE |
| K871290 | Centricell(Tm)JJH · Traditional | Polysciences, Inc. | 08/05/1987SE |
| K870690 | Centriprep ConcentratorJJH · Traditional | Amicon, Inc. | 03/19/1987SE |
| K851393 | Dupont Prep Four-Solvent Retrofit KitJJH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 07/12/1985SE |
Questions and answers
When was Nanosep N10 cleared by the FDA?
Nanosep N10 (K935496) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 162 days after the submission was received.
What is the product code of K935496?
The FDA product code is JJH – Clinical Sample Concentrator, a Class I (low risk) device regulated under 21 CFR 862.2310.