Vivapore 10
FDA 510(k) K943965 · Vivascience, Inc.
510(k) numberK943965
Submission
- Device name
- Vivapore 10
- Applicant
- Vivascience, Inc.
Acton, MA, US - Received
- July 28, 1994
- Decision date
- April 11, 1995
- 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 |
| K941326 | Ultrafree-ClJJH · Traditional | Millipore Corp. | 05/27/1994SE |
| K935496 | Nanosep N10JJH · Traditional | Intersep , Ltd. | 04/26/1994SE |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
Questions and answers
When was Vivapore 10 cleared by the FDA?
Vivapore 10 (K943965) received a 510(k) decision of Substantially Equivalent on April 11, 1995, 257 days after the submission was received.
What is the product code of K943965?
The FDA product code is JJH – Clinical Sample Concentrator, a Class I (low risk) device regulated under 21 CFR 862.2310.