Fructose-1, 6-diphosphate And Nadh (u.v.), Aldolase

Device Code: 348

Product Code(s): CJC

Device Classification Information

• Device Type ID: 348
• Device Name: Fructose-1, 6-diphosphate And Nadh (u.v.), Aldolase
• Regulation Description: Aldolase 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: 862.1040 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: CJC
• 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: 348
• Device: Fructose-1, 6-diphosphate And Nadh (u.v.), Aldolase
• Product Code: CJC
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Aldolase Test System.
• CFR Regulation Number: 862.1040 [🔎]

TPLC Last Update: 2019-04-02 19:33:13