Detectors, Electrochemical, Liquid Chromatography
Electrochemical detectors for liquid chromatography are analytical instruments used in clinical chemistry laboratories to measure the concentration of substances separated by liquid chromatographic techniques. The device is FDA Class 1, the lowest risk category, meaning it is subject only to general controls such as proper labeling and manufacturing standards; no premarket notification is required. It bears product code LEQ and is regulated under 21 CFR 862.2260 within the Clinical Chemistry specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LEQ
- Device Class
- FDA class 1
- Regulation Number
- 862.2260
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962574 | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) | Jul 22, 1996 | Substantially Equivalent | Waters Corporation |
| K903231 | COULOCHEM II | Sep 27, 1990 | Substantially Equivalent | Esa, Inc. |
| K864729 | NEUROCHEMICAL ANALYZER | Apr 13, 1987 | Substantially Equivalent | Esa, Inc. |
| K801439 | MODEL 5100 ELECTROCHEMICAL DETECTOR | Jul 21, 1980 | Substantially Equivalent | Environmental Sciences Assoc., Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.