IDL · Microtome, Accessories
Pathology · 21 CFR 864.3010 · Class 1
Overview
| Product Code | IDL |
|---|---|
| Device Name | Microtome, Accessories |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863616 | KNIFE MAKER | Surgipath Medical Industries, Inc. | Sep 25, 1986 | SESE |
| K831921 | DISPOSABLE MICROTOME BLADES | Polymer Technology Corp. | Jul 29, 1983 | SESE |
| K831308 | DISPOSABLE MICROTOME BLADE | Surgipath Medical Industries, Inc. | May 16, 1983 | SESE |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | American Optical Corp. | Dec 29, 1981 | SESE |
| K801426 | TISSUE-TEK III MICROJECT DISP. BLADE SYS | Miles Laboratories, Inc. | Jul 28, 1980 | SESE |
Top Applicants
- Surgipath Medical Industries, Inc. — 2 clearances
- American Optical Corp. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Polymer Technology Corp. — 1 clearance
