Product code KEW
- Device name
- Slides, Microscope
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3010
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891604 | THE CEN-SLIDE(TM) CENTRIFUGE TUBE | Davstar California, Inc. | 1989-06-16 |
| K890042 | MICROSCOPE SLIDES PRECOATED | Stat Path | 1989-01-13 |
| K882357 | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY | Stat Path | 1988-06-16 |
| K831065 | SECTIONING AID KIT | Technicon Instruments Corp. | 1983-06-08 |
| K820100 | FROSTED GLASS SLIDES | Stan-Pak Ent. | 1982-03-04 |
| K813242 | QUANTIMETRIC 2 TEST KIT | Kallestad Laboratories, Inc. | 1981-12-02 |
| K800232 | ABCO ULTRA SLIDE MICROSCOPE SLIDE | Abco Dealers, Inc. | 1980-02-21 |
| K760278 | SLIDE, LAB-TEK COVERED MICRO | Miles Laboratories, Inc. | 1976-08-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20849832016339 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-28 |
| 20849832016452 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-28 |
| 20849832023139 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-28 |
| 20849832023405 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-28 |
| 20849832023412 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-28 |
| 20849832016322 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-28 |
| 04262400021054 | Bio-Gram Microscope Slides | Bio-Gram Diagnostics GmbH | 2026-10-20 |
| 04062418017151 | KT ™ Premium Slides | Slmp, LLC | 2026-09-21 |
| 04062418017175 | KT ™ Premium Slides | Slmp, LLC | 2026-09-21 |
| 10194484321595 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-11 |
| 10194484321588 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-11 |
| 10194484321571 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-09 |
| 10194484321564 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-09 |
| 10194484321533 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-09 |
| 10194484321335 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-08 |
| 10194484321342 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-08 |
| 10194484321328 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-08 |
| 10194484321311 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-08 |
| 10194484321304 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-08 |
| 10194484321274 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-08 |
| 10194484321267 | N/A (Approved Vendor) | GRAINGER INTERNATIONAL, INC. | 2025-08-08 |
| 10810050855744 | Microscope Slides | TYPENEX MEDICAL LLC | 2025-06-17 |
| 10810050855690 | Microscope Sldies | TYPENEX MEDICAL LLC | 2025-02-03 |
| 10810050855706 | Microscope Slides | TYPENEX MEDICAL LLC | 2025-02-03 |
| 10810050855713 | Microscope Slides | TYPENEX MEDICAL LLC | 2025-02-03 |
| 10810050855720 | Microscope Slides | TYPENEX MEDICAL LLC | 2025-02-03 |
| 10810050855737 | Microscope Slides | TYPENEX MEDICAL LLC | 2025-02-03 |
| 10810050855683 | Microscope Slides | TYPENEX MEDICAL LLC | 2025-01-21 |
| 00380740132552 | Alinity | Abbott GmbH | 2023-11-16 |
| M4454505K1 | Bone Marrow Kit | MEDICAL CHEMICAL CORPORATION | 2020-09-09 |