21 CFR 864.3875 — Processor, Tissue, Automated
Pathology (PA) · Part 864 Subpart D—Pathology Instrumentation and Accessories · § 864.3875
Identification
An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IEO | Processor, Tissue, Automated | 1 | 12 |
