Pancoat T3 Uptake Coated Tube Radioimmunoassay Kit
FDA 510(k) K862447 · Pantex, Div. Bio-Analysis, Inc.
510(k) numberK862447
Submission
- Device name
- Pancoat T3 Uptake Coated Tube Radioimmunoassay Kit
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
Santa Monica, CA, US - Received
- June 27, 1986
- Decision date
- October 7, 1986
- 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 Pancoat T3 Uptake Coated Tube Radioimmunoassay Kit cleared by the FDA?
Pancoat T3 Uptake Coated Tube Radioimmunoassay Kit (K862447) received a 510(k) decision of Substantially Equivalent on October 7, 1986, 102 days after the submission was received.
What is the product code of K862447?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.