KZT — Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin Class II
FDA product code KZT covers "Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin", a Class II medical device regulated under 21 CFR 862.3450. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- KZT
- Device Class
- Class II
- Regulation Number
- 862.3450
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K811067 | marion laboratories | BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M | April 29, 1981 |