Fastpack Free T4 Immunoassay
FDA 510(k) K030329 · Qualigen, Inc.
510(k) numberK030329
Submission
- Device name
- Fastpack Free T4 Immunoassay
- Applicant
- Qualigen, Inc.
Carlsbad, CA, US - Received
- January 31, 2003
- Decision date
- July 3, 2003
- 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 Fastpack Free T4 Immunoassay cleared by the FDA?
Fastpack Free T4 Immunoassay (K030329) received a 510(k) decision of Substantially Equivalent on July 3, 2003, 153 days after the submission was received.
What is the product code of K030329?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.