IDO · Microtome, Rotary
Pathology · 21 CFR 864.3010 · Class 1
Overview
| Product Code | IDO |
|---|---|
| Device Name | Microtome, Rotary |
| 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 |
|---|---|---|---|---|
| K864733 | LKB 2260 MACROTOME | Lkb Instruments, Inc. | Jan 5, 1987 | SESE |
| K863548 | ROTARY MICROTOME | Surgipath Medical Industries, Inc. | Sep 19, 1986 | SESE |
| K843505 | LKB 2230 ROTARY ONE | Lkb Instruments, Inc. | Nov 30, 1984 | SESE |
| K812558 | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME | Miles Laboratories, Inc. | Sep 29, 1981 | SESE |
| K812157 | LKB-BROMMA 2218 HISTORANGE MICROTOME | Lkb Instruments, Inc. | Aug 18, 1981 | SESE |
Top Applicants
- Lkb Instruments, Inc. — 3 clearances
- Miles Laboratories, Inc. — 1 clearance
- Surgipath Medical Industries, Inc. — 1 clearance
