Centrifree Micropartition System
FDA 510(k) K820455 · Amicon, Inc.
510(k) numberK820455
Submission
- Device name
- Centrifree Micropartition System
- Applicant
- Amicon, Inc.
Mchenry, IL, US - Received
- February 19, 1982
- Decision date
- March 15, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRL – Unit, Filter, Membrane
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K822121 | Acro PackJRL · Traditional | Gelman Sciences, Inc. | 08/05/1982SE |
| K820224 | Emit Freelevel System IJRL · Traditional | Syva Co. | 02/23/1982SE |
| K812750 | Il 703, Stat SeparatorJRL · Traditional | Instrumentation Laboratory CO | 01/26/1982SE |
| K813159 | Vacushield TMJRL · Traditional | Gelman Sciences, Inc. | 12/08/1981SE |
| K810829 | AcrodiscJRL · Traditional | Gelman Sciences, Inc. | 04/08/1981SE |
| K801500 | Ultrafree Calcium FilterJRL · Traditional | Millipore Corp. | 08/20/1980SE |
| K790445 | Ultra-FreeJRL · Traditional | Millipore Corp. | 06/28/1979SE |
| K781043 | Cea-Immersible SeparatorJRL · Traditional | Millipore Corp. | 09/15/1978SE |
More from Millipore Corp.
| 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 |
| K893733 | Centricon ConcentratorJJH · Traditional | 07/20/1989SE |
| 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 |
Questions and answers
When was Centrifree Micropartition System cleared by the FDA?
Centrifree Micropartition System (K820455) received a 510(k) decision of Substantially Equivalent on March 15, 1982, 24 days after the submission was received.
What is the product code of K820455?
The FDA product code is JRL – Unit, Filter, Membrane, a Class I (low risk) device regulated under 21 CFR 862.2050.