Free T4 Microwell Eia, Model #7019
FDA 510(k) K982954 · Biomerica, Inc.
510(k) numberK982954
Submission
- Device name
- Free T4 Microwell Eia, Model #7019
- Applicant
- Biomerica, Inc.
Newport Beach, CA, US - Received
- August 24, 1998
- Decision date
- September 24, 1998
- 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 Microwell Eia, Model #7019 cleared by the FDA?
Free T4 Microwell Eia, Model #7019 (K982954) received a 510(k) decision of Substantially Equivalent on September 24, 1998, 31 days after the submission was received.
What is the product code of K982954?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.