L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase

Device Code: 395

Product Code(s): JGG

Device Classification Information

• Device Type ID: 395
• Device Name: L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase
• Regulation Description: Leucine Aminopeptidase Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1460 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JGG
• GMP Exempt: No
• 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: 395
• Device: L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase
• Product Code: JGG
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Leucine Aminopeptidase Test System.
• CFR Regulation Number: 862.1460 [🔎]

TPLC Last Update: 2019-04-02 19:33:59