Product code DOP
- Device name
- Mass Spectrometer, Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2860
- 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 |
|---|---|---|---|
| K992163 | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS | Pdz-Europa , Ltd. | 1999-07-13 |
| K974322 | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM | Europa Scientific, Ltd. | 1997-12-16 |
| K880418 | INCOS 50 MASS SPECTROMETER | Finnigan Corp. | 1988-05-31 |
| K880090 | ION TRAP DETECTOR | Finnigan Corp. | 1988-03-15 |
| K880089 | FINNIGAN MAT TSQ-70 | Finnigan Corp. | 1988-02-11 |
| K872464 | ION TRAP DETECTOR (ITD) | The Perkin-Elmer Corp. | 1987-08-11 |
| K854076 | MGA 2000 GAS ANALYSER | Airspec , Ltd. | 1985-12-11 |
| K810938 | MASS SPECTROMETER-MEDSPECT II | Allied Healthcare Products, Inc. | 1981-04-23 |
| K770994 | FURNACE AUTOSAMPLER, MODEL 155 | Instrumentation Laboratory CO | 1977-08-22 |
| K770637 | MERCURY/HYDRIDE SYSTEM MHS-1 | The Perkin-Elmer Corp. | 1977-06-23 |
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| 07613336231388 | cobas pro i 601 BL | Roche Diagnostics GmbH | 2025-08-08 |
| 07613336231364 | cobas i 601 | Roche Diagnostics GmbH | 2025-07-31 |
| 00842365102568 | Triple Quad™ 4500MD | AB SCIEX (MANUFACTURING) | 2024-06-14 |
| 05061024690009 | Sercon | SERCON LIMITED | 2023-08-30 |
| 00816776020254 | Xevo | WATERS TECHNOLOGIES CORPORATION | 2023-04-06 |
| 06438147371815 | Qsight 210 MD Screening System | Wallac Oy | 2023-03-29 |
| 06438147384709 | Qsight 225 MD Screening System | Wallac Oy | 2023-03-29 |
| 00842365100533 | Citrine Triple Quad™ MS/MS | AB SCIEX (MANUFACTURING) | 2022-09-28 |
| 00842365100540 | Citrine QTRAP MS/MS | AB SCIEX (MANUFACTURING) | 2022-09-28 |
| 00842365102049 | AB SCIEX Triple Quad™ 4500MD | AB SCIEX (MANUFACTURING) | 2022-09-28 |
| 00842365102063 | AB SCIEX QTRAP® 4500MD | AB SCIEX (MANUFACTURING) | 2022-09-28 |
| 05700574007317 | K6460 Triple Quadrupole MS – ESI | AGILENT TECHNOLOGIES, INC. | 2022-08-15 |
| 05700574007300 | K6460 Triple Quadrupole MS – AJS | AGILENT TECHNOLOGIES, INC. | 2022-08-15 |
| 04540217400669 | LCMS-8045CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217400744 | LCMS-8060 CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217400713 | APCI-8050 SET | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217400720 | LCMS-8050 CL | SHIMADZU CORPORATION | 2022-05-20 |
| 04540217400607 | LCMS-8040 CL | SHIMADZU CORPORATION | 2022-05-20 |
| 00816776020346 | Xevo | WATERS TECHNOLOGIES CORPORATION | 2021-10-06 |
| 00816776020179 | Xevo | WATERS TECHNOLOGIES CORPORATION | 2021-10-05 |
| 00816776020155 | Xevo | WATERS TECHNOLOGIES CORPORATION | 2021-10-04 |
| 00816776020162 | Xevo | WATERS TECHNOLOGIES CORPORATION | 2021-10-04 |
| 04540217400621 | LCMS-8050 CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217400645 | LCMS-8060 CL | SHIMADZU CORPORATION | 2020-10-28 |
| 04540217400799 | LCMS-8040 CL | SHIMADZU CORPORATION | 2020-10-28 |
| 00850010566023 | SpectroChip CPM Kit (2x96) | AGENA BIOSCIENCE, INC. | 2020-09-08 |
| 00850010566009 | MassARRAAY Dx | AGENA BIOSCIENCE, INC. | 2020-09-08 |
| 00850010566061 | Calibrant | AGENA BIOSCIENCE, INC. | 2020-09-08 |
| 00850010566030 | SpectroChip CPM Kit (10x96) | AGENA BIOSCIENCE, INC. | 2020-09-08 |