FDA product code GRT: Antiserum, Fluorescent, Mycobacterium Tuberculosis
GRT is the FDA product code for antiserum, fluorescent, mycobacterium tuberculosis. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GRT. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, Mycobacterium Tuberculosis |
| Device class | Class I |
| Regulation | 21 CFR 866.3370 |
| 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 GRT clearance
Top GRT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 1 | 1979-09-24 |
Most recent GRT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791452 | Volu Sol Medical Industries | AGGLUTINOTEST-TUBERCULOSIS | 1979-09-24 | 49 |
Recalls for GRT devices
openFDA lists no recalls for product code GRT.
Frequently asked questions
What is FDA product code GRT?
GRT is the FDA product code for antiserum, fluorescent, mycobacterium tuberculosis. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel.
What device class is GRT?
Class I, regulation 21 CFR 866.3370. Typical premarket route: 510(k).
How long does a 510(k) take for product code GRT?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most GRT clearances?
Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRT
- Run a recall and safety report across every GRT manufacturer
- Watch product code GRT 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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