Free Testosterone AccuBind ELISA Test System
FDA 510(k) K181017 · Monobind, Inc.
510(k) numberK181017
Submission
- Device name
- Free Testosterone AccuBind ELISA Test System
- Applicant
- Monobind, Inc.
Lake Forest, CA, US - Received
- April 10, 2018
- Decision date
- July 20, 2018
- 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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| K971835 | Anti-Thyroglobulin (TG) Microplate ElisaDDC · Traditional | 07/03/1997SE |
| K971834 | Anti-Thyroid Peroxidase (Tpo) Microplate ElisaJNL · Traditional | 07/03/1997SE |
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | 06/24/1997SE |
| K971780 | Thyrotropin(Tsh) ElisaJLW · Traditional | 06/24/1997SE |
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Questions and answers
When was Free Testosterone AccuBind ELISA Test System cleared by the FDA?
Free Testosterone AccuBind ELISA Test System (K181017) received a 510(k) decision of Substantially Equivalent on July 20, 2018, 101 days after the submission was received.
What is the product code of K181017?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.