FDA product code IGB: Solution, Formalin-Sodium Acetate
IGB is the FDA product code for solution, formalin-sodium acetate. 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 IGB. The average 510(k) review took 20 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Formalin-Sodium Acetate |
| 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 IGB clearance
Top IGB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 1 | 1980-12-22 |
Most recent IGB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K803054 | Remel Co. | SAF FIXATIVE | 1980-12-22 | 20 |
Recalls for IGB devices
openFDA lists no recalls for product code IGB.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J0702 — Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg
Frequently asked questions
What is FDA product code IGB?
IGB is the FDA product code for solution, formalin-sodium acetate. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGB?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IGB?
Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).
Which companies have the most IGB clearances?
Remel Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IGB
- Run a recall and safety report across every IGB manufacturer
- Watch product code IGB 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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