GON — Antigen, Cf (Including Cf Control), Rubella Class II
FDA Device Classification
Classification Details
- Product Code
- GON
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K894262 | microbix biosystems | RUBELLA ANTIGEN AND CONTROL ANTIGEN | October 16, 1989 |
| K880157 | syva | MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST | February 4, 1988 |
| K802937 | orion diagnostica | RUBELLA VIRUS ANTIGENS & CONTROLS | December 31, 1980 |
| K802939 | orion diagnostica | HERPES SIMPLEX TYPE I | December 31, 1980 |
| K780996 | microbiological assoc | RUBELISA TEST KIT | November 22, 1978 |