Stratus Free Thyroxine (Free T4) Fluorometric
FDA 510(k) K932912 · Baxter Diagnostics, Inc.
510(k) numberK932912
Submission
- Device name
- Stratus Free Thyroxine (Free T4) Fluorometric
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- June 16, 1993
- Decision date
- October 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Stratus Free Thyroxine (Free T4) Fluorometric cleared by the FDA?
Stratus Free Thyroxine (Free T4) Fluorometric (K932912) received a 510(k) decision of Substantially Equivalent on October 28, 1993, 134 days after the submission was received.
What is the product code of K932912?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.