Product code IBJ
- Device name
- Light, Microscope
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3600
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874750 | VIDEO ANALYZER 4000 | Scientific Imaging, Inc. | 1988-04-25 |
| K874190 | CELL COUNTING GRID GRATICULE | Portable Medical Laboratories, Inc. | 1988-01-05 |
| K874207 | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION | Intl. Remote Imaging Systems | 1988-01-05 |
| K864049 | MCARTHUR MICROSCOPE, STANDARD METAL VERSION | Portable Medical Laboratories, Inc. | 1986-10-29 |
| K854735 | MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. | Portable Medical Laboratories, Inc. | 1985-12-10 |
| K823040 | PATHOLOGY INSTRUMENTATION & ACCESSORIES | Iris Remote Imaging Systems | 1983-01-14 |
| K822207 | 2XC MICROSCOPE | Amarel Precision Instruments, Inc. | 1982-08-05 |
| K821865 | A O MICROSCOPE VIDEO SYSTEM | Warner-Lambert Co. | 1982-07-14 |
| K802818 | PULLEN POCKET SCOPE | P.A. Research Corp. | 1981-04-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00634782089474 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-19 |
| 00634782089467 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-19 |
| 00634782089443 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-19 |
| 00634782089429 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-19 |
| 00634782089238 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-19 |
| 00634782088736 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782089214 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782089191 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782089177 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088972 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088965 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088958 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088934 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088927 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088910 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088712 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088699 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088675 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088484 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088460 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088446 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088422 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088309 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088248 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088149 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088125 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088064 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782088002 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2018-01-12 |
| 00634782053437 | Proscope™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782053734 | Proscope™ Dermascope | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |