Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300
FDA 510(k) K020548 · Monobind
510(k) numberK020548
Submission
- Device name
- Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300
- Applicant
- Monobind
Costa Mesa, CA, US - Received
- February 19, 2002
- Decision date
- April 5, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300 cleared by the FDA?
Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300 (K020548) received a 510(k) decision of Substantially Equivalent on April 5, 2002, 45 days after the submission was received.
What is the product code of K020548?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.