Waters(Tm) 996 Pda
FDA 510(k) K924347 · Millipore Corp.
510(k) numberK924347
Submission
- Device name
- Waters(Tm) 996 Pda
- Applicant
- Millipore Corp.
Milford, MA, US - Received
- August 27, 1992
- Decision date
- December 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KIE – Apparatus, High Pressure Liquid Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964588 | Waters 515 HPLC Pump (515)KIE · Traditional | Waters Corporation | 11/29/1996SE |
| K935666 | Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional | The Perkin-Elmer Corp. | 04/26/1994SE |
| K914841 | Chromatography Clinical Use 75JQRKIE · Traditional | Millipore Corp. | 12/10/1991SE |
| K911299 | Equipment/Material Decontaminating KitKIE · Traditional | Rohm and Haas Co. | 04/08/1991SE |
| K862506 | The Waters Model 990 Photodiode Array DetectorKIE · Traditional | Millipore Corp. | 07/29/1986SE |
| K844947 | Emit Ancillary ReagentsKIE · Traditional | Syva Co. | 06/28/1985SE |
| K844949 | Syva Sample SealKIE · Traditional | Syva Co. | 02/15/1985SE |
| K800556 | Differential Refractive Index DetectorKIE · Traditional | Hewlett-Packard Co. | 03/25/1980SE |
| K800516 | Dupont Instruments Model 870 Liq. Chrom.KIE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/19/1980SE |
| K800289 | LDC Spectromonitor IIIKIE · Traditional | Laboratory Data Control | 02/26/1980SE |
More from Laboratory Data Control
| 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 |
| K941326 | Ultrafree-ClJJH · Traditional | 05/27/1994SE |
| K934069 | Millex, Dualex (Plus, Ultra)FIB · Traditional | 04/21/1994SE |
| 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 Waters(Tm) 996 Pda cleared by the FDA?
Waters(Tm) 996 Pda (K924347) received a 510(k) decision of Substantially Equivalent on December 11, 1992, 106 days after the submission was received.
What is the product code of K924347?
The FDA product code is KIE – Apparatus, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.