DGB — Seminal Fluid, Antigen, Antiserum, Control Class I
FDA product code DGB covers "Seminal Fluid, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5800. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DGB
- Device Class
- Class I
- Regulation Number
- 866.5800
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K861773 | zygotek systems | ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM | July 7, 1986 |