FDA product code IGC: Formalin-Saline
IGC is the FDA product code for formalin-saline. 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 IGC. The average 510(k) review took 245 days (median 245).
Classification
| Field | Value |
|---|---|
| Device name | Formalin-Saline |
| 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 IGC clearance
Top IGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Incstar Corp. | 2 | 1996-07-24 |
Most recent IGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955363 | Incstar Corp. | INCSTAR HSZ I/II IGG ELISA ASSAY | 1996-07-24 | 245 |
| K955362 | Incstar Corp. | INCSTAR HSV I/II IGG FAST ELISA ASSAY | 1996-07-24 | 245 |
Recalls for IGC devices
openFDA lists no recalls for product code IGC.
Frequently asked questions
What is FDA product code IGC?
IGC is the FDA product code for formalin-saline. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGC?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IGC?
Across 2 cleared submissions the average was 245 days from receipt to decision (median 245).
Which companies have the most IGC clearances?
Incstar Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code IGC
- Run a recall and safety report across every IGC manufacturer
- Watch product code IGC 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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