Product code KIE
- Device name
- Apparatus, 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 |
|---|---|---|---|
| K964588 | WATERS 515 HPLC PUMP (515) | Waters Corporation | 1996-11-29 |
| K935666 | PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP | The Perkin-Elmer Corp. | 1994-04-26 |
| K924347 | WATERS(TM) 996 PDA | Millipore Corp. | 1992-12-11 |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | Millipore Corp. | 1991-12-10 |
| K911299 | EQUIPMENT/MATERIAL DECONTAMINATING KIT | Rohm and Haas Co. | 1991-04-08 |
| K862506 | THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR | Millipore Corp. | 1986-07-29 |
| K844947 | EMIT ANCILLARY REAGENTS | Syva Co. | 1985-06-28 |
| K844949 | SYVA SAMPLE SEAL | Syva Co. | 1985-02-15 |
| K800556 | DIFFERENTIAL REFRACTIVE INDEX DETECTOR | Hewlett-Packard Co. | 1980-03-25 |
| K800516 | DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. | E.I. Dupont DE Nemours & Co., Inc. | 1980-03-19 |
| K800289 | LDC SPECTROMONITOR III | Laboratory Data Control | 1980-02-26 |
| K800046 | LDC CHROMATOGRAPHY ACCESSORY MODULE B | Laboratory Data Control | 1980-02-25 |
| K800048 | LDC CONSTAMETRIC III HIGHT PRESS. SOL. | Laboratory Data Control | 1980-01-29 |
| K800047 | LDC UVIII FIXED WAVELENGTH ULTRAVIOLET | Laboratory Data Control | 1980-01-21 |
| K791661 | SYSTEM CONTROLLER 720 SERIES | Waters Assoc., Inc. | 1979-09-24 |
| K790145 | SOLVENT DELIVERY SYSTEM | Waters Assoc., Inc. | 1979-02-15 |
| K782175 | CARTRIDGE HOLDER, RCM 100 | Waters Assoc., Inc. | 1979-02-15 |
| K781915 | DATA MODULE | Waters Assoc., Inc. | 1979-01-10 |
| K781771 | DETECTOR, MODEL 79875A, VARIABLE | Hewlett-Packard Co. | 1978-12-20 |
| K781379 | MODEL 5000, LIQUID CHROMATOGRAPHY | Varian Assoc., Inc. | 1978-09-14 |
| K772364 | AUTO. SAMPLING SYSTEM | Hewlett-Packard Co. | 1978-01-05 |
| K771156 | MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV | The Perkin-Elmer Corp. | 1977-08-02 |
| K770638 | DETECTOR, UV, MOLEL GC-55 | Peokin-Elmer Corp. | 1977-06-24 |
| K761351 | L080 SERIES LIQUID CHROMATOGRAPH | Hewlett-Packard Co. | 1977-02-02 |
| K761219 | SERIES II LIQUID CHROMATOGRAPH | The Perkin-Elmer Corp. | 1977-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842365100519 | Jasper HPLC System | AB SCIEX (MANUFACTURING) | 2022-09-28 |
| 05700574007225 | 1260 Infinity II LC System Clinical Edition | AGILENT TECHNOLOGIES, INC. | 2022-08-15 |
| 04540217420353 | FCV-32AH CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420476 | LC-30AD CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420377 | SPD-M30A CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420346 | CTO-30A CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420278 | LC-30AD CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420261 | LC-20ADXR CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420186 | FCV-32AH CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420131 | SIL-20ACXR CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420070 | CBM-20A CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217420568 | LC-40D XR CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420629 | SPD-40 CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420612 | FCV-S CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420605 | CTO-40C CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420599 | PLATE CHANGER CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420582 | SIL-40C XR CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420575 | SIL-40C X3 CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420551 | LC-40B X3 CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420544 | LC-40D X3 CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420537 | DGU-405 CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420520 | CBM-40 CL | SHIMADZU CORPORATION | 2021-01-15 |
| 04540217420056 | CTO-20AC CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217420179 | LC-30AD CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217420193 | RESERVOIR SWITCHING VALVE KIT FOR LC-30AD CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217420216 | SPD-M30A CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217420247 | CBM-20A CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217420308 | SIL-20ACXR CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217420315 | SIL-30AC CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217420384 | SPD-20AV CL | SHIMADZU CORPORATION | 2020-10-28 |