Cartridge Holder, RCM 100
FDA 510(k) K782175 · Waters Assoc., Inc.
510(k) numberK782175
Submission
- Device name
- Cartridge Holder, RCM 100
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- December 28, 1978
- Decision date
- February 15, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K811975 | Model 480 Variable Wavelength Ultra ViolJJQ · Traditional | 07/27/1981SE |
| K802481 | 7FRENCH Flow Directed Triple Lumen CathDYG · Traditional | 10/31/1980SE |
| K801852 | MRM-2 Oxygen Consumption MonitorBZL · Traditional | 08/20/1980SE |
| K801431 | Pan-Am Myelogram TrayFMI · Traditional | 08/12/1980SE |
| K791661 | System Controller 720 SeriesKIE · Traditional | 09/24/1979SE |
| K791026 | 4F Sterile Balloon-Less, Catheter 913-28KRB · Traditional | 06/22/1979SE |
| K790145 | Solvent Delivery SystemKIE · Traditional | 02/15/1979SE |
| K781805 | Cardiac Computers, CO-10 & CO-10RDXG · Traditional | 01/29/1979SE |
| K781915 | Data ModuleKIE · Traditional | 01/10/1979SE |
| K781692 | Calibrator, DynamicDXM · Traditional | 11/29/1978SE |
Questions and answers
When was Cartridge Holder, RCM 100 cleared by the FDA?
Cartridge Holder, RCM 100 (K782175) received a 510(k) decision of Substantially Equivalent on February 15, 1979, 49 days after the submission was received.
What is the product code of K782175?
The FDA product code is KIE – Apparatus, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.