N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin

Device Code: 537

Product Code(s): JNO

Device Classification Information

• Device Type ID: 537
• Device Name: N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
• Regulation Description: Trypsin 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: 862.1725 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JNO
• 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: 537
• Device: N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
• Product Code: JNO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Trypsin Test System.
• CFR Regulation Number: 862.1725 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	PerkinElmer Life And Analytical Sciences, Wallac, OY	III	Oct-11-2018

TPLC Last Update: 2019-04-02 19:36:09