U.V. Light, Tlc
The UV Light TLC device is a thin layer chromatography accessory using ultraviolet light illumination to visualize separated compounds on TLC plates in clinical chemistry and toxicology laboratory analyses. It is classified as FDA Class 1, the lowest risk category, and is subject only to general controls without premarket notification requirements. The device is regulated under 21 CFR 862.2270 within the Clinical Chemistry specialty and is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- DJS
- Device Class
- FDA class 1
- Regulation Number
- 862.2270
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K771486 | DUAL LAB-LITE LIGHT BOX | Aug 22, 1977 | Substantially Equivalent | Technilab |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.