Light, Microscope
FDA product code IBJ · Class I (low risk) · 21 CFR 864.3600 · Pathology
9510(k) clearances
0PMA approvals
2recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874750 | Video Analyzer 4000IBJ · Traditional | Scientific Imaging, Inc. | 04/25/1988SE |
| K874207 | The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional | Intl. Remote Imaging Systems | 01/05/1988SE |
| K874190 | Cell Counting Grid GraticuleIBJ · Traditional | Portable Medical Laboratories, Inc. | 01/05/1988SE |
| K864049 | Mcarthur Microscope, Standard Metal VersionIBJ · Traditional | Portable Medical Laboratories, Inc. | 10/29/1986SE |
| K854735 | Mcarthur Microscope Plastic Version with Acc.IBJ · Traditional | Portable Medical Laboratories, Inc. | 12/10/1985SE |
| K823040 | Pathology Instrumentation & AccessoriesIBJ · Traditional | Iris Remote Imaging Systems | 01/14/1983SE |
| K822207 | 2XC MicroscopeIBJ · Traditional | Amarel Precision Instruments, Inc. | 08/05/1982SE |
| K821865 | A O Microscope Video SystemIBJ · Traditional | Warner-Lambert Co. | 07/14/1982SE |
| K802818 | Pullen Pocket ScopeIBJ · Traditional | P.A. Research Corp. | 04/17/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0799-2014 Class II | Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all…Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard… | Zeiss, Carl Inc | 12/20/2013Terminated |
| Z-1744-2013 Class II | Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes…Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes… | Zeiss, Carl Inc | 05/28/2013Terminated |