Regulator, Temperature
The Regulator, Temperature is a clinical laboratory device or controller used to maintain a specified temperature in incubators, water baths, heat blocks, or other thermally controlled laboratory instruments, ensuring stable reaction conditions for clinical chemistry assays and specimen processing. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRR 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
- JRR
- 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 |
|---|---|---|---|---|
| K822132 | DADE CHILL TRAY | Aug 05, 1982 | Substantially Equivalent | American Dade |
| K801148 | HEMOGASTAT | Jun 09, 1980 | Substantially Equivalent | Therapac, Inc. |
| K780757 | KRYORACK/4 | Jun 06, 1978 | Substantially Equivalent | Streck Laboratories, Inc. |
| K761337 | AQUAMATIC K-MODULE MODEL K-10 | Jan 10, 1977 | Substantially Equivalent | Gorman Rupp Industries |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.