KER · Container, Embedding
Pathology · 21 CFR 864.3010 · Class 1
Overview
| Product Code | KER |
|---|---|
| Device Name | Container, Embedding |
| 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 |
|---|---|---|---|---|
| K831922 | EMBEDDING RING | Polymer Technology Corp. | Jul 29, 1983 | SESE |
| K831900 | MACLEAN-FOGG, DISP. BASE MOLD | Polymer Technology Corp. | Jul 28, 1983 | SESE |
| K831333 | EMBEDDING RINGS | Surgipath Medical Industries, Inc. | May 25, 1983 | SESE |
| K831335 | DISPOSABLE BASE MOLD | Surgipath Medical Industries, Inc. | May 16, 1983 | SESE |
| K772149 | LANCER BIOPSY HOLDER | Sherwood Medical Industries | Nov 22, 1977 | SESE |
Top Applicants
- Polymer Technology Corp. — 2 clearances
- Surgipath Medical Industries, Inc. — 2 clearances
- Sherwood Medical Industries — 1 clearance
