GRP — Antisera, All Types, H. Influenza Class II
FDA product code GRP covers "Antisera, All Types, H. Influenza", a Class II medical device regulated under 21 CFR 866.3300. Submissions are reviewed by the Microbiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
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 | Feb 7, 1989 |
| K854490 | American Micro Scan | IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES | Dec 27, 1985 |
| K831525 | Seragen Diagnostics | H-FLU B ELISA TEST | Sep 29, 1983 |
| K823348 | Diagnostica | H. INFLUENZA B ANTISERA FOR CIE | Dec 28, 1982 |
| K821266 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BBL DIRECTIGEN MENINGITIS TEST KIT | Jun 1, 1982 |
| K820192 | Hyland Therapeutic Div., Travenol Laboratories | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | Mar 11, 1982 |