Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)
FDA 510(k) K041866 · Axis-Shield Diagnostics, Ltd.
510(k) numberK041866
Submission
- Device name
- Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)
- Applicant
- Axis-Shield Diagnostics, Ltd.
Dundee, GB - Received
- July 9, 2004
- Decision date
- September 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1680
- Specialty
- Clinical Chemistry
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Questions and answers
When was Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia) cleared by the FDA?
Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia) (K041866) received a 510(k) decision of Substantially Equivalent on September 29, 2004, 82 days after the submission was received.
What is the product code of K041866?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.