GRP — Antisera, All Types, H. Influenza Class II
FDA Device Classification
Classification Details
- Product Code
- GRP
- Device Class
- Class II
- Regulation Number
- 866.3300
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K884967 | armkel | BACTIGEN(R) H. INFLUENZAE TYPE B | February 7, 1989 |
| K854490 | american micro scan | IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES | December 27, 1985 |
| K831525 | seragen diagnostics | H-FLU B ELISA TEST | September 29, 1983 |
| K823348 | diagnostica | H. INFLUENZA B ANTISERA FOR CIE | December 28, 1982 |
| K821266 | bd becton dickinson vacutainer systems preanalytic | BBL DIRECTIGEN MENINGITIS TEST KIT | June 1, 1982 |
| K820192 | hyland therapeutic div., travenol laboratories | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | March 11, 1982 |