IBK · Microscope, Fluorescence/U.V.
Pathology · 21 CFR 864.3600 · Class 1
Overview
| Product Code | IBK |
|---|---|
| Device Name | Microscope, Fluorescence/U.V. |
| Regulation | 21 CFR 864.3600 |
| Device Class | Class 1 |
| Review Panel | Pathology |
| GMP Exempt | Yes |
Identification
Microscopes and accessories are optical instruments used to enlarge images of specimens, preparations, and cultures for medical purposes. Variations of microscopes and accessories (through a change in the light source) used for medical purposes include the following:(1) Phase contrast microscopes, which permit visualization of unstained preparations by altering the phase relationship of light that passes around the object and through the object. (2) Fluorescense microscopes, which permit examination of specimens stained with fluorochromes that fluoresce under ultraviolet light. (3) Inverted stage microscopes, which permit examination of tissue cultures or other biological specimens contained in bottles or tubes with the light source mounted above the specimen.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770652 | FLUORESCENCE ILLUMINATOR ACCESSORY | Bausch & Lomb, Inc. | Jul 6, 1977 | SESE |
Top Applicants
- Bausch & Lomb, Inc. — 1 clearance
