Testoterone Elisa
FDA 510(k) K973900 · Kmi Diagnostics, Inc.
510(k) numberK973900
Submission
- Device name
- Testoterone Elisa
- Applicant
- Kmi Diagnostics, Inc.
Minneapolis, MN, US - Received
- October 14, 1997
- Decision date
- February 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K190121 | Ids SHBGCDZ · Traditional | Immunodiagnostic Systems , Ltd. | 06/17/2019SE |
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Questions and answers
When was Testoterone Elisa cleared by the FDA?
Testoterone Elisa (K973900) received a 510(k) decision of Substantially Equivalent on February 24, 1998, 133 days after the submission was received.
What is the product code of K973900?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.