Product code LDM
- Device name
- Instrumentation, High Pressure Liquid Chromatography
- 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 |
|---|---|---|---|
| K960392 | CDM | Bio-Rad | 1996-07-08 |
| K961557 | ALLIANCE 2690 SEPARATIONS MODULE | Waters Corporation | 1996-07-05 |
| K942451 | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM | Bio-Rad | 1994-11-10 |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | Millipore Corp. | 1992-09-11 |
| K920136 | WATERS 717 AUTOSAMPLER | Millipore Corp. | 1992-02-19 |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Millipore Corp. | 1990-09-11 |
| K884886 | MODEL 250 LIQUID CHROMOTAGRAPHY PUMP | The Perkin-Elmer Corp. | 1989-02-02 |
| K872582 | HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM | Millipore Corp. | 1987-07-16 |
| K870949 | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM | Millipore Corp. | 1987-04-22 |
| K862178 | ISOPURE LC SYSTEM | The Perkin-Elmer Corp. | 1986-07-14 |
| K850272 | WATERS 740 DATA MODULE-PLOTTER INTEGRATOR | Millipore Corp. | 1985-03-06 |
| K850359 | WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D | Millipore Corp. | 1985-03-05 |
| K833113 | REPORTING INTEGRATOR 3392A | Hewlett-Packard Co. | 1983-11-21 |
| K832375 | LIQUID CHROMATOGRAPH 1090 SERIES | Hewlett-Packard Co. | 1983-10-14 |
| K821727 | SERIES 10 LIQUID CHROMOTOGRAPH | The Perkin-Elmer Corp. | 1982-06-22 |
| K821219 | SERIES 4 LIQUID CHROMATOGRAPH | The Perkin-Elmer Corp. | 1982-05-28 |
| K810304 | MODEL LC-85 UV DETECTOR | The Perkin-Elmer Corp. | 1981-02-25 |
| K802031 | 3390A REPORTING INTEGRATOR | Hewlett-Packard Co. | 1980-09-16 |
| K780933 | PREP I AUTOMATED SAMPLE PROCESSOR | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03610522126750 | D-10 | BIO-RAD LABORATORIES, INC. | 2023-06-12 |
| 00847817006098 | D-10 | BIO-RAD LABORATORIES, INC. | 2023-01-31 |
| 00847817014949 | VARIANT II | BIO-RAD LABORATORIES, INC. | 2023-01-31 |
| 00847817015786 | VARIANT II TURBO | BIO-RAD LABORATORIES, INC. | 2023-01-31 |
| 03610522060696 | D-100 | BIO-RAD LABORATORIES, INC. | 2023-01-31 |
| 00847817003516 | D-10 | BIO-RAD LABORATORIES, INC. | 2023-01-31 |
| 00816776020445 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2022-03-01 |
| 00816776020452 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2022-03-01 |
| 00816776020469 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2022-03-01 |
| 00816776020476 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2022-03-01 |
| 00816776020315 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-06 |
| 00816776020087 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-04 |
| 00816776020117 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-04 |
| 00816776020100 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-04 |
| 00816776020094 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-04 |
| 00816776020025 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-01 |
| 00816776020032 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-01 |
| 00816776020049 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-01 |
| 00816776020063 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-01 |
| 00816776020070 | Acquity | WATERS TECHNOLOGIES CORPORATION | 2021-10-01 |
| 00847817007163 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-07-01 |
| 00847817006791 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-06-24 |