FDA product code MIG: Strip, Test Isoniazid
MIG is the FDA product code for strip, test isoniazid. It is a Unclassified device, reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under MIG, from 2 different applicants. The average 510(k) review took 431 days (median 431).
Classification
| Field | Value |
|---|---|
| Device name | Strip, Test Isoniazid |
| Device class | Unclassified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Top MIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ferguson Medical | 1 | 1998-03-19 |
| Dynagen, Inc. | 1 | 1992-02-24 |
Most recent MIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962615 | Ferguson Medical | TUMORLOCALIZER MRI | 1998-03-19 | 624 |
| K912888 | Dynagen, Inc. | URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL | 1992-02-24 | 238 |
Recalls for MIG devices
openFDA lists no recalls for product code MIG.
Frequently asked questions
What is FDA product code MIG?
MIG is the FDA product code for strip, test isoniazid. It is a Unclassified device, reviewed by the Clinical Toxicology panel.
What device class is MIG?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MIG?
Across 2 cleared submissions the average was 431 days from receipt to decision (median 431).
Which companies have the most MIG clearances?
Ferguson Medical (1); Dynagen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MIG
- Run a recall and safety report across every MIG manufacturer
- Watch product code MIG 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.
All Clinical Toxicology product codes · FDA product code lookup