Oreai-Q-Tu Test
FDA 510(k) K802464 · Organon, Inc.
510(k) numberK802464
Submission
- Device name
- Oreai-Q-Tu Test
- Applicant
- Organon, Inc.
Mchenry, IL, US - Received
- October 9, 1980
- Decision date
- October 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHQ – Radioassay, Triiodothyronine Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1715
- Specialty
- Clinical Chemistry
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Questions and answers
When was Oreai-Q-Tu Test cleared by the FDA?
Oreai-Q-Tu Test (K802464) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 22 days after the submission was received.
What is the product code of K802464?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.