GON
5 FDA 510(k) clearances · Product code
42 daysmedian time to decision
162 days90th percentile
5clearances measured
FDA profile
- Official device name
- Antigen, Cf (Including Cf Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RUBELLA ANTIGEN AND CONTROL ANTIGEN (K894262) | Microbix Biosystems, Inc. | 1989-10-16 |
| MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST (K880157) | Syva Co. | 1988-02-04 |
| HERPES SIMPLEX TYPE I (K802939) | Orion Diagnostica, Inc. | 1980-12-31 |
| RUBELLA VIRUS ANTIGENS & CONTROLS (K802937) | Orion Diagnostica, Inc. | 1980-12-31 |
| RUBELISA TEST KIT (K780996) | Microbiological Assoc. | 1978-11-22 |
Track GON automatically
Every clearance here is in the API, with alerts when new ones post.