Unit, Drying
The Unit, Drying is a clinical laboratory device used to remove moisture from specimens, reagents, or laboratory equipment by controlled drying processes, supporting sample preparation and the preservation of analytical materials used in clinical chemistry testing. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRJ 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
- JRJ
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K791077 | BECKMAN ELECTROPHORESIS OVEN/INCUBATOR | Jul 24, 1979 | Substantially Equivalent | Beckman Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.