FDA product code IFT: Glutaraldehyde
IFT is the FDA product code for glutaraldehyde. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IFT. The average 510(k) review took 364 days (median 364).
Classification
| Field | Value |
|---|---|
| Device name | Glutaraldehyde |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IFT clearance
Top IFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chimera Research & Chemical, Inc. | 1 | 1995-02-17 |
Most recent IFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940768 | Chimera Research & Chemical, Inc. | AD PERFECT | 1995-02-17 | 364 |
Recalls for IFT devices
openFDA lists no recalls for product code IFT.
Frequently asked questions
What is FDA product code IFT?
IFT is the FDA product code for glutaraldehyde. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IFT?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IFT?
Across 1 cleared submissions the average was 364 days from receipt to decision (median 364).
Which companies have the most IFT clearances?
Chimera Research & Chemical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IFT
- Run a recall and safety report across every IFT manufacturer
- Watch product code IFT 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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