Waters 515 HPLC Pump (515)
FDA 510(k) K964588 · Waters Corporation
510(k) numberK964588
Submission
- Device name
- Waters 515 HPLC Pump (515)
- Applicant
- Waters Corporation
Milford, MA, US - Received
- November 15, 1996
- Decision date
- November 29, 1996
- 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 |
|---|---|---|---|
| K935666 | Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional | The Perkin-Elmer Corp. | 04/26/1994SE |
| K924347 | Waters(Tm) 996 PdaKIE · Traditional | Millipore Corp. | 12/11/1992SE |
| 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 |
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| K063868 | Masstrak Immunosuppressants KitMLM · Traditional | 05/25/2007SE |
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| K973074 | 2487 Dual Wavelength Absorbance DetectorKZR · Traditional | 10/06/1997SE |
| K962574 | Waters 474 Scanning Flourescence Detector (474)LEQ · Traditional | 07/22/1996SE |
| K961557 | Alliance 2690 Separations ModuleLDM · Traditional | 07/05/1996SE |
Questions and answers
When was Waters 515 HPLC Pump (515) cleared by the FDA?
Waters 515 HPLC Pump (515) (K964588) received a 510(k) decision of Substantially Equivalent on November 29, 1996, 14 days after the submission was received.
What is the product code of K964588?
The FDA product code is KIE – Apparatus, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.