Light, Microscope
A microscope light source is an illumination component used in laboratory microscopy to provide the light required for visualizing stained tissue sections and other biological specimens through optical microscopes. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IBJ, regulated under 21 CFR 864.3600, in the Pathology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IBJ
- Device Class
- FDA class 1
- Regulation Number
- 864.3600
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874750 | VIDEO ANALYZER 4000 | Apr 25, 1988 | Substantially Equivalent | Scientific Imaging, Inc. |
| K874207 | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION | Jan 05, 1988 | Substantially Equivalent | Intl. Remote Imaging Systems |
| K874190 | CELL COUNTING GRID GRATICULE | Jan 05, 1988 | Substantially Equivalent | Portable Medical Laboratories, Inc. |
| K864049 | MCARTHUR MICROSCOPE, STANDARD METAL VERSION | Oct 29, 1986 | Substantially Equivalent | Portable Medical Laboratories, Inc. |
| K854735 | MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. | Dec 10, 1985 | Substantially Equivalent | Portable Medical Laboratories, Inc. |
| K823040 | PATHOLOGY INSTRUMENTATION & ACCESSORIES | Jan 14, 1983 | Substantially Equivalent | Iris Remote Imaging Systems |
| K822207 | 2XC MICROSCOPE | Aug 05, 1982 | Substantially Equivalent | Amarel Precision Instruments, Inc. |
| K821865 | A O MICROSCOPE VIDEO SYSTEM | Jul 14, 1982 | Substantially Equivalent | Warner-Lambert Co. |
| K802818 | PULLEN POCKET SCOPE | Apr 17, 1981 | Substantially Equivalent | P.A. Research Corp. |
FEI Numbers
This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.