Amerlite Mab FT4 Assay
FDA 510(k) K920247 · Eastman Kodak Company
510(k) numberK920247
Submission
- Device name
- Amerlite Mab FT4 Assay
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- January 21, 1992
- Decision date
- March 2, 1992
- 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 Amerlite Mab FT4 Assay cleared by the FDA?
Amerlite Mab FT4 Assay (K920247) received a 510(k) decision of Substantially Equivalent on March 2, 1992, 41 days after the submission was received.
What is the product code of K920247?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.