Mass Spectrometer, Clinical Use
The Mass Spectrometer for Clinical Use is a laboratory analytical instrument that uses mass spectrometry to identify and quantify analytes in patient specimens across a broad range of clinical chemistry applications, including drug testing and metabolic analysis. It is a Class 1 device subject to general controls only, with no premarket notification required. The product code is DOP, regulated under 21 CFR 862.2860, within the Clinical Chemistry specialty. No special regulatory flags apply.
Research product code DOP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DOP
- Device Class
- FDA class 1
- Regulation Number
- 862.2860
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992163 | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS | Jul 13, 1999 | Substantially Equivalent | Pdz-Europa , Ltd. |
| K974322 | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM | Dec 16, 1997 | Substantially Equivalent | Europa Scientific, Ltd. |
| K880418 | INCOS 50 MASS SPECTROMETER | May 31, 1988 | Substantially Equivalent | Finnigan Corp. |
| K880090 | ION TRAP DETECTOR | Mar 15, 1988 | Substantially Equivalent | Finnigan Corp. |
| K880089 | FINNIGAN MAT TSQ-70 | Feb 11, 1988 | Substantially Equivalent | Finnigan Corp. |
| K872464 | ION TRAP DETECTOR (ITD) | Aug 11, 1987 | Substantially Equivalent | The Perkin-Elmer Corp. |
| K854076 | MGA 2000 GAS ANALYSER | Dec 11, 1985 | Substantially Equivalent | Airspec , Ltd. |
| K810938 | MASS SPECTROMETER-MEDSPECT II | Apr 23, 1981 | Substantially Equivalent | Allied Healthcare Products, Inc. |
| K770994 | FURNACE AUTOSAMPLER, MODEL 155 | Aug 22, 1977 | Substantially Equivalent | Instrumentation Laboratory CO |
| K770637 | MERCURY/HYDRIDE SYSTEM MHS-1 | Jun 23, 1977 | Substantially Equivalent | The Perkin-Elmer Corp. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.