FDA product code GON: Antigen, Cf (Including Cf Control), Rubella
GON is the FDA product code for antigen, cf (including cf control), rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under GON, from 4 different applicants. The average 510(k) review took 77 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf (Including Cf Control), Rubella |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GON clearance
Top GON applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orion Diagnostica, Inc. | 2 | 1980-12-31 |
| Microbix Biosystems, Inc. | 1 | 1989-10-16 |
| Syva Co. | 1 | 1988-02-04 |
| Microbiological Assoc. | 1 | 1978-11-22 |
Most recent GON clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894262 | Microbix Biosystems, Inc. | RUBELLA ANTIGEN AND CONTROL ANTIGEN | 1989-10-16 | 117 |
| K880157 | Syva Co. | MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST | 1988-02-04 | 22 |
| K802937 | Orion Diagnostica, Inc. | RUBELLA VIRUS ANTIGENS & CONTROLS | 1980-12-31 | 42 |
| K802939 | Orion Diagnostica, Inc. | HERPES SIMPLEX TYPE I | 1980-12-31 | 42 |
| K780996 | Microbiological Assoc. | RUBELISA TEST KIT | 1978-11-22 | 162 |
Recalls for GON devices
openFDA lists no recalls for product code GON.
Frequently asked questions
What is FDA product code GON?
GON is the FDA product code for antigen, cf (including cf control), rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is GON?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code GON?
Across 5 cleared submissions the average was 77 days from receipt to decision (median 42).
Which companies have the most GON clearances?
Orion Diagnostica, Inc. (2); Microbix Biosystems, Inc. (1); Syva Co. (1); Microbiological Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GON
- Run a recall and safety report across every GON manufacturer
- Watch product code GON for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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