FDA product code IBK: Microscope, Fluorescence/U.V.
IBK is the FDA product code for microscope, fluorescence/u.v.. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IBK. The average 510(k) review took 91 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Fluorescence/U.V. |
| Device class | Class I |
| Regulation | 21 CFR 864.3600 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IBK clearance
Top IBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bausch & Lomb, Inc. | 1 | 1977-07-06 |
Most recent IBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770652 | Bausch & Lomb, Inc. | FLUORESCENCE ILLUMINATOR ACCESSORY | 1977-07-06 | 91 |
Recalls for IBK devices
openFDA lists no recalls for product code IBK.
Frequently asked questions
What is FDA product code IBK?
IBK is the FDA product code for microscope, fluorescence/u.v.. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel.
What device class is IBK?
Class I, regulation 21 CFR 864.3600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IBK?
Across 1 cleared submissions the average was 91 days from receipt to decision (median 91).
Which companies have the most IBK clearances?
Bausch & Lomb, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IBK
- Run a recall and safety report across every IBK manufacturer
- Watch product code IBK 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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