FDA product code GOL: Antigen, Ha (Including Ha Control), Rubella
GOL is the FDA product code for antigen, ha (including ha control), rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 21 510(k) submissions under GOL, from 13 different applicants. The average 510(k) review took 77 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Ha (Including Ha 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 GOL clearance
Top GOL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 1984-04-17 |
| Flow Laboratories, Inc. | 3 | 1980-09-16 |
| Intl. Diagnostic Technology | 2 | 1984-06-07 |
| Calbiochem-Behring Corp. | 2 | 1981-03-11 |
| Litton Bionetics | 2 | 1980-06-30 |
8 more applicants have GOL clearances. See the full list in Caduvo.
Most recent GOL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841174 | Intl. Diagnostic Technology | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | 1984-06-07 | 80 |
| K834032 | Abbott Laboratories | RUBAQUICK DIAGNOSTIC KIT | 1984-04-17 | 147 |
| K810309 | Calbiochem-Behring Corp. | RUBELLA ANTIBODIES TEST REAGENTS | 1981-03-11 | 34 |
| K802508 | M.A. Bioproducts | RUBELISA IGM TEST KIT | 1980-12-18 | 64 |
| K802102 | Calbiochem-Behring Corp. | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | 1980-12-18 | 106 |
Recalls for GOL devices
openFDA lists no recalls for product code GOL.
Frequently asked questions
What is FDA product code GOL?
GOL is the FDA product code for antigen, ha (including ha control), rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is GOL?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code GOL?
Across 21 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most GOL clearances?
Abbott Laboratories (3); Flow Laboratories, Inc. (3); Intl. Diagnostic Technology (2); Calbiochem-Behring Corp. (2); Litton Bionetics (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GOL
- Run a recall and safety report across every GOL manufacturer
- Watch product code GOL 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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