IDZ · Cassettes, Tissue
Pathology · 21 CFR 864.3010 · Class 1
Overview
| Product Code | IDZ |
|---|---|
| Device Name | Cassettes, Tissue |
| 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 |
|---|---|---|---|---|
| K863483 | CASSETTE EMBOSSEER | Surgipath Medical Industries, Inc. | Sep 16, 1986 | SESE |
| K862457 | LYNX EL MICROSCOPY TISSUE PROCESSOR | Australian Biomedical Corporation , Ltd. | Jul 16, 1986 | SESE |
| K833857 | MACLEAN-FOGG, TISSUE CASSETTES | Polymer Technology Corp. | Dec 2, 1983 | SESE |
| K831334 | TISSUE CASSETTES FOR PROCESSING-EM BED | Surgipath Medical Industries, Inc. | May 25, 1983 | SESE |
| K760623 | LANCER PARAPLAST HISTO PROCESS CASSETTE | Sherwood Medical Industries | Sep 27, 1976 | SESE |
Top Applicants
- Surgipath Medical Industries, Inc. — 2 clearances
- Australian Biomedical Corporation , Ltd. — 1 clearance
- Polymer Technology Corp. — 1 clearance
- Sherwood Medical Industries — 1 clearance
