FDA product code IGG: Formaldehyde (Formalin, Formol)
IGG is the FDA product code for formaldehyde (formalin, formol). It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under IGG, from 5 different applicants. The average 510(k) review took 27 days (median 25). FDA has posted 1 recall for IGG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Formaldehyde (Formalin, Formol) |
| 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 IGG clearance
Top IGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 3 | 1980-11-12 |
| Anatech, Ltd. | 1 | 1988-06-15 |
| Surgipath Medical Industries, Inc. | 1 | 1986-04-11 |
| Richard-Allan Medical Ind., Inc. | 1 | 1981-07-28 |
| Central Labs. Assoc. MD Pathologists | 1 | 1977-08-22 |
Most recent IGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882268 | Anatech, Ltd. | ZINC FORMALIN CONCENTRATE | 1988-06-15 | 15 |
| K861201 | Surgipath Medical Industries, Inc. | FORMALDEHYDE SOLUTION, 37% | 1986-04-11 | 11 |
| K811794 | Richard-Allan Medical Ind., Inc. | 37% FORMALDEHYDE | 1981-07-28 | 34 |
| K802506 | Meridian Diagnostics, Inc. | PLEASCENT OR FORMA-SCENT | 1980-11-12 | 28 |
| K792707 | Meridian Diagnostics, Inc. | PARA-PAK SAF | 1980-01-21 | 25 |
Recalls for IGG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-19.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code IGG?
IGG is the FDA product code for formaldehyde (formalin, formol). It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGG?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IGG?
Across 7 cleared submissions the average was 27 days from receipt to decision (median 25).
Which companies have the most IGG clearances?
Meridian Diagnostics, Inc. (3); Anatech, Ltd. (1); Surgipath Medical Industries, Inc. (1); Richard-Allan Medical Ind., Inc. (1); Central Labs. Assoc. MD Pathologists (1).
Have IGG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-10-19.
Next steps
- Run an FDA pathway report with predicate devices for product code IGG
- Run a recall and safety report across every IGG manufacturer
- Watch product code IGG 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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