FDA product code IAC: Van Gieson'S Stain
IAC is the FDA product code for van gieson's stain. 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 IAC. The average 510(k) review took 9 days (median 9).
Classification
| Field | Value |
|---|---|
| Device name | Van Gieson'S Stain |
| 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 IAC clearance
Top IAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 1986-10-29 |
Most recent IAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864074 | Sigma Diagnostics, Inc. | ELASTIC STAIN | 1986-10-29 | 9 |
Recalls for IAC devices
openFDA lists no recalls for product code IAC.
Frequently asked questions
What is FDA product code IAC?
IAC is the FDA product code for van gieson's stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IAC?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IAC?
Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).
Which companies have the most IAC clearances?
Sigma Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IAC
- Run a recall and safety report across every IAC manufacturer
- Watch product code IAC 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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