21 CFR 864.3010 — Microtome, Accessories
Pathology (PA) · Part 864 Subpart D—Pathology Instrumentation and Accessories · § 864.3010
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IDL | Microtome, Accessories | 1 | 5 | |
| IDM | Microtome, Ultra | 1 | 1 | |
| IDN | Microtome, Freezing Attachment | 1 | 0 | |
| IDO | Microtome, Rotary | 1 | 5 | |
| IDP | Microtome, Cryostat | 1 | 1 | |
| IDQ | Infiltrator | 1 | 0 | |
| IDR | Ovens, Paraffin | 1 | 0 | |
| IDS | Melting Pot, Paraffin | 1 | 1 | |
| IDT | Apparatus, Melting Point, Paraffin | 1 | 0 | |
| IDW | Dispensers, Paraffin | 1 | 1 | |
| IDX | Sieves, Tissue | 1 | 0 | |
| IDY | Bath, Flotation, Tissue | 1 | 0 | |
| IDZ | Cassettes, Tissue | 1 | 5 | |
| IEG | Table, Slide Warming | 1 | 1 | |
| IEH | Lamps, Slide Warming | 1 | 0 | |
| IHJ | Blender, Sputum | 1 | 0 | |
| KDZ | Device, Decalcifier, Electrolytic | 1 | 0 | |
| KER | Container, Embedding | 1 | 5 | |
| KES | Coverslips, Microscope Slide | 1 | 3 | |
| KET | Filters, Cell Collection, Tissue Processing | 1 | 5 | |
| KEW | Slides, Microscope | 1 | 8 | |
| KFL | Microtome, Sliding | 1 | 0 | |
| KJG | Tube, Tissue Culture | 1 | 1 | |
| LEC | Grinder, Tissue | 1 | 0 | |
| MJI | Specimen/Tissue, Identification Orientation | 1 | 0 | |
| MXT | Device, Accessory, Cooling Plate For Tissue Embedding Station | 1 | 0 |
