KET · Filters, Cell Collection, Tissue Processing
Pathology · 21 CFR 864.3010 · Class 1
Overview
| Product Code | KET |
|---|---|
| Device Name | Filters, Cell Collection, Tissue Processing |
| 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 |
|---|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | Corning Medical & Scientific | Jan 12, 1988 | SESE |
| K870196 | PCTE MICROPOROUS MEMBRANE FILTER | Poretics Corp. | May 12, 1987 | SESE |
| K844671 | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON | Corning Medical & Scientific | Feb 25, 1985 | SESE |
| K840556 | DISPOSABLE SYRINGE FILTERS | Corning Medical & Scientific | Mar 5, 1984 | SESE |
| K792633 | STERILIZATION PROCESS/OUTERWRAP | Procter & Gamble Mfg. Co. | Jan 11, 1980 | SESE |
Top Applicants
- Corning Medical & Scientific — 3 clearances
- Poretics Corp. — 1 clearance
- Procter & Gamble Mfg. Co. — 1 clearance
