GTI — Antisera, Fluorescent, All Groups, N. Meningitidis Class II
FDA Device Classification
Classification Details
- Product Code
- GTI
- Device Class
- Class II
- Regulation Number
- 866.3390
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K920274 | bd becton dickinson vacutainer systems preanalytic | DIRECTIGEN NEISSERIA MENINGITIDIS TEST | March 18, 1992 |
| K841308 | bd becton dickinson vacutainer systems preanalytic | DIRECTIGEN MENNINGITIS TEST KIT | May 2, 1984 |