KEW
8 FDA 510(k) clearances · Product code
38 daysmedian time to decision
88 days90th percentile
8clearances measured
FDA profile
- Official device name
- Slides, Microscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1995: 1 · 1998: 4 · 2020: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THE CEN-SLIDE(TM) CENTRIFUGE TUBE (K891604) | Davstar California, Inc. | 1989-06-16 |
| MICROSCOPE SLIDES PRECOATED (K890042) | Stat Path | 1989-01-13 |
| MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (K882357) | Stat Path | 1988-06-16 |
| SECTIONING AID KIT (K831065) | Technicon Instruments Corp. | 1983-06-08 |
| FROSTED GLASS SLIDES (K820100) | Stan-Pak Ent. | 1982-03-04 |
| QUANTIMETRIC 2 TEST KIT (K813242) | Kallestad Laboratories, Inc. | 1981-12-02 |
| ABCO ULTRA SLIDE MICROSCOPE SLIDE (K800232) | Abco Dealers, Inc. | 1980-02-21 |
| SLIDE, LAB-TEK COVERED MICRO (K760278) | Miles Laboratories, Inc. | 1976-08-30 |
Track KEW automatically
Every clearance here is in the API, with alerts when new ones post.