Radioimmunoassay, 17-hydroxyprogesterone

Device Code: 506

Product Code(s): JLX

Device Classification Information

• Device Type ID: 506
• Device Name: Radioimmunoassay, 17-hydroxyprogesterone
• Regulation Description: 17-Hydroxyprogesterone 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: 862.1395 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JLX
• 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: 506
• Device: Radioimmunoassay, 17-hydroxyprogesterone
• Product Code: JLX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: 17-Hydroxyprogesterone Test System.
• CFR Regulation Number: 862.1395 [🔎]

Device Problems
Contamination Of Device Ingredient Or Reagent	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:35:46