Waters 717 Autosampler
FDA 510(k) K920136 · Millipore Corp.
510(k) numberK920136
Submission
- Device name
- Waters 717 Autosampler
- Applicant
- Millipore Corp.
Milford, MA, US - Received
- January 13, 1992
- Decision date
- February 19, 1992
- 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
Other 510(k)s with product code LDM
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|---|---|---|---|
| K960392 | CDMLDM · Traditional | Bio-Rad | 07/08/1996SE |
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| K942451 | Bio-Rad Clinical Data Management SystemLDM · Traditional | Bio-Rad | 11/10/1994SE |
| K922388 | Waters(Tm) LC Module I for Clinical UseLDM · Traditional | Millipore Corp. | 09/11/1992SE |
| K903647 | Module 486 Variable Wavelength Tunable Uv/Vis DeteLDM · Traditional | Millipore Corp. | 09/11/1990SE |
| 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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| K941326 | Ultrafree-ClJJH · Traditional | 05/27/1994SE |
| 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 |
| K914841 | Chromatography Clinical Use 75JQRKIE · Traditional | 12/10/1991SE |
Questions and answers
When was Waters 717 Autosampler cleared by the FDA?
Waters 717 Autosampler (K920136) received a 510(k) decision of Substantially Equivalent on February 19, 1992, 37 days after the submission was received.
What is the product code of K920136?
The FDA product code is LDM – Instrumentation, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.