FDA product code IAB: Toluidine Blue
IAB is the FDA product code for toluidine blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IAB. The average 510(k) review took 63 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Toluidine Blue |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IAB clearance
Top IAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgipath Medical Industries, Inc. | 1 | 1985-01-30 |
Most recent IAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844640 | Surgipath Medical Industries, Inc. | POLYSTAT, BIOLOGICAL STAIN | 1985-01-30 | 63 |
Recalls for IAB devices
openFDA lists no recalls for product code IAB.
Frequently asked questions
What is FDA product code IAB?
IAB is the FDA product code for toluidine blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IAB?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IAB?
Across 1 cleared submissions the average was 63 days from receipt to decision (median 63).
Which companies have the most IAB clearances?
Surgipath Medical Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IAB
- Run a recall and safety report across every IAB manufacturer
- Watch product code IAB 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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