Centricon Concentrator
FDA 510(k) K893733 · Amicon, Inc.
510(k) numberK893733
Submission
- Device name
- Centricon Concentrator
- Applicant
- Amicon, Inc.
Danvers, MA, US - Received
- May 17, 1989
- Decision date
- July 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K935496 | Nanosep N10JJH · Traditional | Intersep , Ltd. | 04/26/1994SE |
| K930168 | Centricon -50 ConcentratorJJH · Traditional | Amicon, Inc. | 08/05/1993SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K930168 | Centricon -50 ConcentratorJJH · Traditional | 08/05/1993SE |
| K902837 | Amicon Diafilter 30 HemoconcentratorKDI · Traditional | 11/01/1990SE |
| K901286 | Amicon Hemoconcentrator SetKDI · Traditional | 05/18/1990SE |
| K900280 | Centriprep 100JJP · Traditional | 02/16/1990SE |
| K895405 | Amicon Minifilter Plus HemofilterKDI · Traditional | 01/11/1990SE |
| K892645 | Amicon Vitafiber Flo-Path Biorect/Vls Cell Cult SyKJF · Traditional | 06/13/1989SE |
| K875121 | Amicon Equaline Fluid Balance SystemKPF · Traditional | 02/19/1988SE |
| K870690 | Centriprep ConcentratorJJH · Traditional | 03/19/1987SE |
| K863823 | Amicon Diafilter HemofilterKDI · Traditional | 11/06/1986SE |
| K853510 | Minifilter HemofilterKDI · Traditional | 09/12/1985SE |
Questions and answers
When was Centricon Concentrator cleared by the FDA?
Centricon Concentrator (K893733) received a 510(k) decision of Substantially Equivalent on July 20, 1989, 64 days after the submission was received.
What is the product code of K893733?
The FDA product code is JJH – Clinical Sample Concentrator, a Class I (low risk) device regulated under 21 CFR 862.2310.