Product Code: DJS FDA class 1 21 CFR 862.2270

U.V. Light, Tlc

Clinical Chemistry

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.

510(k)s
1
FEI Numbers
3
Registration Numbers
3
Unique Applicants
1
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K771486 DUAL LAB-LITE LIGHT BOX

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.