Cuvette, Thermostated
The Cuvette, Thermostated is a clinical laboratory accessory consisting of a temperature-regulated optical cuvette used to maintain biological specimens or reaction mixtures at a defined temperature during spectrophotometric or other optical measurement procedures in clinical chemistry assays. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JRI and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JRI
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- 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 |
|---|---|---|---|---|
| K873656 | MEDATRON CUVETTE DISC | Dec 14, 1987 | Substantially Equivalent | Medatron, Inc. |
| K780888 | THERMO SET ELECTRONIC TEM. CONTROLLER | Jun 28, 1978 | Substantially Equivalent | Gilford Instrument Laboratories, Inc. |
| K760769 | TEMPERATURE REGULATED FIVE CELL HOLDERS | Nov 30, 1976 | Substantially Equivalent | The Perkin-Elmer Corp. |
| K760197 | ACCUVETTE II | Jul 19, 1976 | Substantially Equivalent | Coulter Electronics, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.