FDA product code IFQ: Formulations, Mercuric Chloride For Tissue
IFQ is the FDA product code for formulations, mercuric chloride for tissue. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under IFQ, from 2 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Formulations, Mercuric Chloride For Tissue |
| 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 IFQ clearance
Top IFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marion Laboratories, Inc. | 1 | 1980-01-24 |
| Meridian Diagnostics, Inc. | 1 | 1980-01-24 |
Most recent IFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792654 | Marion Laboratories, Inc. | CULTURETTE BRAND-PVA/FORMALIN KIT | 1980-01-24 | 29 |
| K792714 | Meridian Diagnostics, Inc. | PARA-PAK PVA | 1980-01-24 | 28 |
Recalls for IFQ devices
openFDA lists no recalls for product code IFQ.
Frequently asked questions
What is FDA product code IFQ?
IFQ is the FDA product code for formulations, mercuric chloride for tissue. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IFQ?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IFQ?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most IFQ clearances?
Marion Laboratories, Inc. (1); Meridian Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IFQ
- Run a recall and safety report across every IFQ manufacturer
- Watch product code IFQ 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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