Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine

Device Code: 528

Product Code(s): JNB

Device Classification Information

• Device Type ID: 528
• Device Name: Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
• Regulation Description: Phenylalanine 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)
• CFR Regulation Number: 862.1555 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JNB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 528
• Device: Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
• Product Code: JNB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Phenylalanine Test System.
• CFR Regulation Number: 862.1555 [🔎]

TPLC Last Update: 2019-04-02 19:36:01