Product code KZR
- Device name
- Chromatography (Liquid, Gel), Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2260
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973074 | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | Waters Corporation | 1997-10-06 |
| K931227 | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 | U.S. Drug Testing, Inc. | 1993-05-06 |
| K905538 | COLUMNS LIQUID CHROMATOGRAPHY DPM | Millpore Corp. | 1991-01-25 |
| K861392 | SYVA SOLID PHASE COLUMNS SYSTEM II | Syva Co. | 1986-06-13 |
| K860197 | SERIES 410 LC PUMP | The Perkin-Elmer Corp. | 1986-03-17 |
| K851945 | VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM | Varian Assoc., Inc. | 1985-05-24 |
| K843568 | LIQUID CHROMATOGRAPH 400 | The Perkin-Elmer Corp. | 1984-11-20 |
| K841890 | VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY | Varian Assoc., Inc. | 1984-06-14 |
| K840977 | LIQUID CHROMATOGRAPHIC DETECTOR LC-95 | The Perkin-Elmer Corp. | 1984-04-19 |
| K832201 | CHROM-PREP | Hamilton Co. | 1983-08-16 |
| K802725 | VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS | Varian Assoc., Inc. | 1980-12-11 |
| K780944 | LIQUID CHROMATOGRAPH MODEL 850 | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| K780945 | LIQUID CHROMATOGRAPH MODEL 860 | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| K770255 | LC-65T DETECTOR AND OVEN | The Perkin-Elmer Corp. | 1977-02-25 |
| K770254 | CHROMATOGRAPH, SERIES 3, LIQUID | The Perkin-Elmer Corp. | 1977-02-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250317558084 | Restrictor Capillary | Chromsystems Instruments + Chemicals GmbH | 2026-01-22 |
| 04250317553454 | HPLC Column | Chromsystems Instruments + Chemicals GmbH | 2024-02-08 |
| 04250317553461 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2024-02-08 |
| 04250317519924 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317547262 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317538628 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317532039 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317520074 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317520067 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317520050 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317520043 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317520012 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317520005 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519986 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519979 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519948 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519931 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519917 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519887 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519870 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519863 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519856 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519825 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519818 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519795 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317519757 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317502537 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317502506 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317502452 | Precolumn Cartridge | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317501813 | HPLC Column | Chromsystems Instruments + Chemicals GmbH | 2020-08-20 |