FDA product code IBJ: Light, Microscope
IBJ is the FDA product code for light, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel. FDA has cleared 9 510(k) submissions under IBJ, from 7 different applicants. The average 510(k) review took 71 days (median 82). FDA has posted 2 recalls for IBJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Light, Microscope |
| 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 IBJ clearance
Top IBJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Portable Medical Laboratories, Inc. | 3 | 1988-01-05 |
| Scientific Imaging, Inc. | 1 | 1988-04-25 |
| Intl. Remote Imaging Systems | 1 | 1988-01-05 |
| Iris Remote Imaging Systems | 1 | 1983-01-14 |
| Amarel Precision Instruments, Inc. | 1 | 1982-08-05 |
2 more applicants have IBJ clearances. See the full list in Caduvo.
Most recent IBJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874750 | Scientific Imaging, Inc. | VIDEO ANALYZER 4000 | 1988-04-25 | 159 |
| K874190 | Portable Medical Laboratories, Inc. | CELL COUNTING GRID GRATICULE | 1988-01-05 | 83 |
| K874207 | Intl. Remote Imaging Systems | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION | 1988-01-05 | 82 |
| K864049 | Portable Medical Laboratories, Inc. | MCARTHUR MICROSCOPE, STANDARD METAL VERSION | 1986-10-29 | 12 |
| K854735 | Portable Medical Laboratories, Inc. | MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. | 1985-12-10 | 15 |
Recalls for IBJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-12-20.
Frequently asked questions
What is FDA product code IBJ?
IBJ is the FDA product code for light, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel.
What device class is IBJ?
Class I, regulation 21 CFR 864.3600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IBJ?
Across 9 cleared submissions the average was 71 days from receipt to decision (median 82).
Which companies have the most IBJ clearances?
Portable Medical Laboratories, Inc. (3); Scientific Imaging, Inc. (1); Intl. Remote Imaging Systems (1); Iris Remote Imaging Systems (1); Amarel Precision Instruments, Inc. (1).
Have IBJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code IBJ
- Run a recall and safety report across every IBJ manufacturer
- Watch product code IBJ 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times