LJK — Antisera, If, Toxoplasma Gondii Class II
FDA Device Classification
Classification Details
- Product Code
- LJK
- Device Class
- Class II
- Regulation Number
- 866.3780
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K974261 | boston biomedica | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | December 11, 1997 |
| K911771 | bd becton dickinson vacutainer systems preanalytic | ARD(TM) ANTIMICROBIAL REMOVAL DEVICE | July 1, 1991 |
| K861122 | microbiological research | THE GOLDEN QUAD TEST (TOXO) | February 2, 1987 |
| K861460 | widran urological group | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 | May 2, 1986 |
| K832069 | bionetic laboratory products | TOXO IPA KIT IAN INDIRECT FLUORESCENT | September 26, 1983 |
| K822605 | immulok | TOXOPLASMA GONDII ANTIBODY IGG | October 27, 1982 |