FDA product code IBL: Microscope, Inverted Stage, Tissue Culture
IBL is the FDA product code for microscope, inverted stage, tissue culture. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel. Devices under IBL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Inverted Stage, Tissue Culture |
| Device class | Class I |
| Regulation | 21 CFR 864.3600 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IBL devices
openFDA lists no recalls for product code IBL.
Frequently asked questions
What is FDA product code IBL?
IBL is the FDA product code for microscope, inverted stage, tissue culture. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel.
What device class is IBL?
Class I, regulation 21 CFR 864.3600. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IBL
- Run a recall and safety report across every IBL manufacturer
- Watch product code IBL 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.