Slides, Microscope
Microscope Slides are flat pieces of glass used as a substrate on which tissue sections, cell preparations, or other biological specimens are mounted for examination under a light microscope, forming a fundamental component of histological and cytological analysis. 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 KEW, 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
- KEW
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K891604 | THE CEN-SLIDE(TM) CENTRIFUGE TUBE | Jun 16, 1989 | Substantially Equivalent | Davstar California, Inc. |
| K890042 | MICROSCOPE SLIDES PRECOATED | Jan 13, 1989 | Substantially Equivalent | Stat Path |
| K882357 | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY | Jun 16, 1988 | Substantially Equivalent | Stat Path |
| K831065 | SECTIONING AID KIT | Jun 08, 1983 | Substantially Equivalent | Technicon Instruments Corp. |
| K820100 | FROSTED GLASS SLIDES | Mar 04, 1982 | Substantially Equivalent | Stan-Pak Ent. |
| K813242 | QUANTIMETRIC 2 TEST KIT | Dec 02, 1981 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K800232 | ABCO ULTRA SLIDE MICROSCOPE SLIDE | Feb 21, 1980 | Substantially Equivalent | Abco Dealers, Inc. |
| K760278 | SLIDE, LAB-TEK COVERED MICRO | Aug 30, 1976 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.