Imx Free T4 Calculation
FDA 510(k) K903384 · Abbott Laboratories
510(k) numberK903384
Submission
- Device name
- Imx Free T4 Calculation
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 27, 1990
- Decision date
- September 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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Questions and answers
When was Imx Free T4 Calculation cleared by the FDA?
Imx Free T4 Calculation (K903384) received a 510(k) decision of Substantially Equivalent on September 10, 1990, 45 days after the submission was received.
What is the product code of K903384?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.