Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase

Device Code: 515

Product Code(s): JMK

Device Classification Information

• Device Type ID: 515
• Device Name: Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
• Regulation Description: Hydroxybutyric Dehydrogenase 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: 862.1380 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JMK
• 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: 515
• Device: Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
• Product Code: JMK
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Hydroxybutyric Dehydrogenase Test System.
• CFR Regulation Number: 862.1380 [🔎]

TPLC Last Update: 2019-04-02 19:35:53