Coverslips, Microscope Slide
Microscope Slide Coverslips are thin, flat pieces of glass or plastic used in pathology and histology to cover tissue specimens or other preparations mounted on microscope slides, protecting them and providing an optically uniform surface for microscopic examination. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KES, regulated under 21 CFR 864.3010, within the Pathology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KES
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K882881 | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER | Jul 28, 1988 | Substantially Equivalent | Sakura Finetek U.S.A., Inc. |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent | Abco Dealers, Inc. |
| K771925 | KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP | Nov 02, 1977 | Substantially Equivalent | Harleco |
FEI Numbers
This FDA classification entry is associated with 76 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 76 registration numbers. Click on an entry to view related FDA registrations.