Radioassay, Triiodothyronine Uptake

Device Code: 588

Product Code(s): KHQ

Device Classification Information

• Device Type ID: 588
• Device Name: Radioassay, Triiodothyronine Uptake
• Regulation Description: Triiodothyronine Uptake 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: 862.1715 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KHQ
• 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: 588
• Device: Radioassay, Triiodothyronine Uptake
• Product Code: KHQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Triiodothyronine Uptake Test System.
• CFR Regulation Number: 862.1715 [🔎]

Device Problems
Low Test Results	2
High Test Results	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Tosoh Bioscience Inc	II	Jun-05-2018

TPLC Last Update: 2019-04-02 19:36:57