NDR — Enzyme Immunoassay, Inhibin-A Class I
FDA product code NDR covers "Enzyme Immunoassay, Inhibin-A", a Class I medical device regulated under 21 CFR 862.1260. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NDR
- Device Class
- Class I
- Regulation Number
- 862.1260
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K002128 | diagnostic systems laboratories | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | December 5, 2000 |