Ultrafree-Cl
FDA 510(k) K941326 · Millipore Corp.
510(k) numberK941326
Submission
- Device name
- Ultrafree-Cl
- Applicant
- Millipore Corp.
Bedford, MA, US - Received
- March 18, 1994
- Decision date
- May 27, 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K093815 | Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124OMG · Traditional | 03/12/2010SE |
| K081527 | Light Diagnostics HSV 1/2 Typing Dfa KitGQL · Traditional | 04/01/2009SE |
| K023892 | Millex VV, GV, and HV Syringe Filter UnitsBSN · Traditional | 01/17/2003SE |
| K013988 | Millex GP Sterilizing Filter Unit, Model SLGP 033 RBSN · Special | 04/04/2002SE |
| K963717 | Millex - MP Filter Unit (SLMPO25SS/SLMPL25SS)BSN · Traditional | 06/10/1997SE |
| K934069 | Millex, Dualex (Plus, Ultra)FIB · Traditional | 04/21/1994SE |
| K924347 | Waters(Tm) 996 PdaKIE · Traditional | 12/11/1992SE |
| K922388 | Waters(Tm) LC Module I for Clinical UseLDM · Traditional | 09/11/1992SE |
| K920136 | Waters 717 AutosamplerLDM · Traditional | 02/19/1992SE |
| K914841 | Chromatography Clinical Use 75JQRKIE · Traditional | 12/10/1991SE |
Questions and answers
When was Ultrafree-Cl cleared by the FDA?
Ultrafree-Cl (K941326) received a 510(k) decision of Substantially Equivalent on May 27, 1994, 70 days after the submission was received.
What is the product code of K941326?
The FDA product code is JJH – Clinical Sample Concentrator, a Class I (low risk) device regulated under 21 CFR 862.2310.