Flagen TM Free T4
FDA 510(k) K904539 · Cyberfluor, Inc.
510(k) numberK904539
Submission
- Device name
- Flagen TM Free T4
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- October 4, 1990
- Decision date
- November 30, 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 Flagen TM Free T4 cleared by the FDA?
Flagen TM Free T4 (K904539) received a 510(k) decision of Substantially Equivalent on November 30, 1990, 57 days after the submission was received.
What is the product code of K904539?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.