KLP — Amikacin Serum Assay Class II
FDA product code KLP covers "Amikacin Serum Assay", a Class II medical device regulated under 21 CFR 862.3035. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLP
- Device Class
- Class II
- Regulation Number
- 862.3035
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K032279 | roche diagnostics | ONLINE TDM AMIKA | October 10, 2003 |
| K873426 | em diagnostic systems | EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 | October 29, 1987 |
| K790899 | bd becton dickinson vacutainer systems preanalytic | BACTEC | May 23, 1979 |
| K780949 | monitor science | BIO-MONITOR AMIKACIN | August 14, 1978 |