Testosterone Serozyme(Tm) Enzyme Immunoassay
FDA 510(k) K924257 · Serono-Baker Diagnostics, Inc.
510(k) numberK924257
Submission
- Device name
- Testosterone Serozyme(Tm) Enzyme Immunoassay
- Applicant
- Serono-Baker Diagnostics, Inc.
Allentown, PA, US - Received
- August 24, 1992
- Decision date
- November 30, 1992
- 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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More from Qualigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915164 | Sri Testosterone Enzyme ImmunoassayCDZ · Traditional | 03/02/1992SE |
| K914886 | Sri(Tm) Cortisol Enzyme Immunoassay(Mag Sol Phase)CGR · Traditional | 03/02/1992SE |
| K915602 | Sri Digoxin Enzyme ImmunoassayKXT · Traditional | 01/17/1992SE |
| K912937 | SR1 Free T4 Enzyme ImmunoassayCEC · Traditional | 11/19/1991SE |
| K914462 | Sri Progesterone Enzyme Immunoassay(Mag Sold Phas)JLS · Traditional | 10/23/1991SE |
| K911912 | SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)KHQ · Traditional | 09/18/1991SE |
| K911217 | SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)KLI · Traditional | 08/16/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | 07/25/1991SE |
| K911396 | SR1 Estradiol Enzyme ImmunoassayCHP · Traditional | 05/28/1991SE |
| K910837 | Sri TSH Immunenzymetric AssayJLW · Traditional | 05/24/1991SE |
Questions and answers
When was Testosterone Serozyme(Tm) Enzyme Immunoassay cleared by the FDA?
Testosterone Serozyme(Tm) Enzyme Immunoassay (K924257) received a 510(k) decision of Substantially Equivalent on November 30, 1992, 98 days after the submission was received.
What is the product code of K924257?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.