Microscope, Fluorescence/U.V.
A fluorescence/UV microscope is a laboratory instrument used to examine specimens labeled with fluorescent dyes or probes by illuminating the sample with ultraviolet or specific wavelength light, enabling visualization of specific cellular structures or molecular targets. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IBK, 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
- IBK
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K770652 | FLUORESCENCE ILLUMINATOR ACCESSORY | Jul 06, 1977 | Substantially Equivalent | Bausch & Lomb, Inc. |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.