Alliance 2690 Separations Module
FDA 510(k) K961557 · Waters Corporation
510(k) numberK961557
Submission
- Device name
- Alliance 2690 Separations Module
- Applicant
- Waters Corporation
Milford, MA, US - Received
- April 22, 1996
- Decision date
- July 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDM – Instrumentation, High Pressure Liquid Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
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| K884886 | Model 250 Liquid Chromotagraphy PumpLDM · Traditional | The Perkin-Elmer Corp. | 02/02/1989SE |
| K872582 | High Pressure Liquid Chromatography SystemLDM · Traditional | Millipore Corp. | 07/16/1987SE |
| K870949 | Waters 650 Advanced Protein Purification SystemLDM · Traditional | Millipore Corp. | 04/22/1987SE |
| K862178 | Isopure LC SystemLDM · Traditional | The Perkin-Elmer Corp. | 07/14/1986SE |
| K850272 | Waters 740 Data Module-Plotter IntegratorLDM · Traditional | Millipore Corp. | 03/06/1985SE |
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| K973074 | 2487 Dual Wavelength Absorbance DetectorKZR · Traditional | 10/06/1997SE |
| K964588 | Waters 515 HPLC Pump (515)KIE · Traditional | 11/29/1996SE |
| K962574 | Waters 474 Scanning Flourescence Detector (474)LEQ · Traditional | 07/22/1996SE |
Questions and answers
When was Alliance 2690 Separations Module cleared by the FDA?
Alliance 2690 Separations Module (K961557) received a 510(k) decision of Substantially Equivalent on July 5, 1996, 74 days after the submission was received.
What is the product code of K961557?
The FDA product code is LDM – Instrumentation, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.