U.v. Light, Tlc

Device Code: 5969

Product Code(s): DJS

Device Classification Information

• Device Type ID: 5969
• Device Name: U.v. Light, Tlc
• Regulation Description: Thin-layer Chromatography System For Clinical Use.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Toxicology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.2270 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DJS
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5969
• Device: U.v. Light, Tlc
• Product Code: DJS
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Thin-layer Chromatography System For Clinical Use.
• CFR Regulation Number: 862.2270 [🔎]

TPLC Last Update: 2019-04-02 21:15:24