KEW · Slides, Microscope
Pathology · 21 CFR 864.3010 · Class 1
Overview
| Product Code | KEW |
|---|---|
| Device Name | Slides, Microscope |
| Regulation | 21 CFR 864.3010 |
| Device Class | Class 1 |
| Review Panel | Pathology |
| GMP Exempt | Yes |
Identification
Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891604 | THE CEN-SLIDE(TM) CENTRIFUGE TUBE | Davstar California, Inc. | Jun 16, 1989 | SESE |
| K890042 | MICROSCOPE SLIDES PRECOATED | Stat Path | Jan 13, 1989 | SESE |
| K882357 | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY | Stat Path | Jun 16, 1988 | SESE |
| K831065 | SECTIONING AID KIT | Technicon Instruments Corp. | Jun 8, 1983 | SESE |
| K820100 | FROSTED GLASS SLIDES | Stan-Pak Ent. | Mar 4, 1982 | SESE |
| K813242 | QUANTIMETRIC 2 TEST KIT | Kallestad Laboratories, Inc. | Dec 2, 1981 | SESE |
| K800232 | ABCO ULTRA SLIDE MICROSCOPE SLIDE | Abco Dealers, Inc. | Feb 21, 1980 | SESE |
| K760278 | SLIDE, LAB-TEK COVERED MICRO | Miles Laboratories, Inc. | Aug 30, 1976 | SESE |
Top Applicants
- Stat Path — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- Davstar California, Inc. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
