LJF — Device, Antimicrobial Drug Removal Class I
FDA product code LJF covers "Device, Antimicrobial Drug Removal", a Class I medical device regulated under 21 CFR 866.2560. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LJF
- Device Class
- Class I
- Regulation Number
- 866.2560
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003104 | organon teknika | BACT/ALERT CSR | October 20, 2000 |
| K830372 | marion laboratories | ARTIMICROBIAL REMOVAL DEVICE | April 8, 1983 |
| K830363 | bd becton dickinson vacutainer systems preanalytic | BACTEC 170 TRYPTIC SOY BROTH W/RESINS | March 24, 1983 |
| K822344 | marion laboratories | ANTIMICROBIAL REMOVAL DEVICE (ARD) | August 25, 1982 |