Catalytic Methods, Amylase

Device Code: 382

Product Code(s): JFJ

Device Classification Information

• Device Type ID: 382
• Device Name: Catalytic Methods, Amylase
• Regulation Description: Amylase 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: 862.1070 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JFJ
• 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: 382
• Device: Catalytic Methods, Amylase
• Product Code: JFJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Amylase Test System.
• CFR Regulation Number: 862.1070 [🔎]

Device Problems
High Test Results	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:33:46