SPINSEP-T3
FDA 510(k) K771854 · Nuclear Diagnostics, Inc.
510(k) numberK771854
Submission
- Device name
- SPINSEP-T3
- Applicant
- Nuclear Diagnostics, Inc.
Mchenry, IL, US - Received
- September 28, 1977
- Decision date
- December 22, 1977
- 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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| K862312 | Enzlipase, Enzymatic Lipase KitCHI · Traditional | 09/26/1986SE |
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Questions and answers
When was SPINSEP-T3 cleared by the FDA?
SPINSEP-T3 (K771854) received a 510(k) decision of Substantially Equivalent on December 22, 1977, 85 days after the submission was received.
What is the product code of K771854?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.