Slides, Microscope
FDA product code KEW · Class I (low risk) · 21 CFR 864.3010 · Pathology
8510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891604 | The Cen-Slide(Tm) Centrifuge TubeKEW · Traditional | Davstar California, Inc. | 06/16/1989SE |
| K890042 | Microscope Slides PrecoatedKEW · Traditional | Stat Path | 01/13/1989SE |
| K882357 | Microscope Slides Precoated W/Histogrip & Poly-LyKEW · Traditional | Stat Path | 06/16/1988SE |
| K831065 | Sectioning Aid KitKEW · Traditional | Technicon Instruments Corp. | 06/08/1983SE |
| K820100 | Frosted Glass SlidesKEW · Traditional | Stan-Pak Ent. | 03/04/1982SE |
| K813242 | Quantimetric 2 Test KitKEW · Traditional | Kallestad Laboratories, Inc. | 12/02/1981SE |
| K800232 | Abco Ultra Slide Microscope SlideKEW · Traditional | Abco Dealers, Inc. | 02/21/1980SE |
| K760278 | Slide, Lab-Tek Covered MicroKEW · Traditional | Miles Laboratories, Inc. | 08/30/1976SE |