Apparatus, High Pressure Liquid Chromatography
FDA product code KIE · Class I (low risk) · 21 CFR 862.2260 · Clinical Chemistry
25510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 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 |
| 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 |
| K800046 | LDC Chromatography Accessory Module BKIE · Traditional | Laboratory Data Control | 02/25/1980SE |
| K800048 | LDC Constametric III Hight Press. Sol.KIE · Traditional | Laboratory Data Control | 01/29/1980SE |
| K800047 | LDC Uviii Fixed Wavelength UltravioletKIE · Traditional | Laboratory Data Control | 01/21/1980SE |
| K791661 | System Controller 720 SeriesKIE · Traditional | Waters Assoc., Inc. | 09/24/1979SE |
| K790145 | Solvent Delivery SystemKIE · Traditional | Waters Assoc., Inc. | 02/15/1979SE |
| K782175 | Cartridge Holder, RCM 100KIE · Traditional | Waters Assoc., Inc. | 02/15/1979SE |
| K781915 | Data ModuleKIE · Traditional | Waters Assoc., Inc. | 01/10/1979SE |
| K781771 | Detector, Model 79875A, VariableKIE · Traditional | Hewlett-Packard Co. | 12/20/1978SE |
| K781379 | Model 5000, Liquid ChromatographyKIE · Traditional | Varian Assoc., Inc. | 09/14/1978SE |
| K772364 | Auto. Sampling SystemKIE · Traditional | Hewlett-Packard Co. | 01/05/1978SE |
| K771156 | Monitor, Liq. Chromatography LC-15 UVKIE · Traditional | The Perkin-Elmer Corp. | 08/02/1977SE |
| K770638 | Detector, UV, Molel GC-55KIE · Traditional | Peokin-Elmer Corp. | 06/24/1977SE |
| K761351 | L080 Series Liquid ChromatographKIE · Traditional | Hewlett-Packard Co. | 02/02/1977SE |
| K761219 | Series II Liquid ChromatographKIE · Traditional | The Perkin-Elmer Corp. | 02/01/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0554-2025 Class II | Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CLThere have been cases of failure of the main board due to condensation water occurring in the gap between… | Shimadzu Corp. Analytical & Measuring… | 10/09/2024Open, Classified |
| Z-0553-2025 Class II | Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CLThere have been cases of failure of the main board due to condensation water drained from the Peltier… | Shimadzu Corp. Analytical & Measuring… | 10/09/2024Open, Classified |