NDR · Enzyme Immunoassay, Inhibin-A
Clinical Chemistry · 21 CFR 862.1260 · Class 1
Overview
| Product Code | NDR |
|---|---|
| Device Name | Enzyme Immunoassay, Inhibin-A |
| Regulation | 21 CFR 862.1260 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | Diagnostic Systems Laboratories, Inc. | Dec 5, 2000 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 1 clearance
