IEO · Processor, Tissue, Automated
Pathology · 21 CFR 864.3875 · Class 1
Overview
| Product Code | IEO |
|---|---|
| Device Name | Processor, Tissue, Automated |
| Regulation | 21 CFR 864.3875 |
| Device Class | Class 1 |
| Review Panel | Pathology |
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.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Innovative Medical Systems, Inc. | Dec 29, 1992 | SESE |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Innovative Medical Systems, Inc. | Sep 2, 1988 | SESE |
| K881165 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | Sakura Finetek U.S.A., Inc. | Jul 1, 1988 | SESE |
| K853938 | LX 300 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | Oct 10, 1985 | SESE |
| K851054 | LX120 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | May 15, 1985 | SESE |
| K843506 | LKB 2189 ULTROPROCESSOR | Lkb Instruments, Inc. | Nov 30, 1984 | SESE |
| K834599 | AUTOTECHNICON V TISSUE PROCESS SYS | Technicon Instruments Corp. | Feb 4, 1984 | SESE |
| K831313 | TISSUE-TEK V.I.P. 100/200 | Miles Laboratories, Inc. | Jul 28, 1983 | SESE |
| K801513 | TISSUE PROCESSING SYSTEM | Innovative Medical Systems, Inc. | Jul 28, 1980 | SESE |
| K801427 | TISSUE-TEK III MINI-RAPID PROCESSOR | Miles Laboratories, Inc. | Jul 28, 1980 | SESE |
| K771308 | TISSUE-TEK III V.I.P. | Miles Laboratories, Inc. | Aug 22, 1977 | SESE |
| K761062 | HISTO-TEK W/ AUTOMATIC COVERSLIPPER | Miles Laboratories, Inc. | Mar 7, 1977 | SESE |
Top Applicants
- Innovative Medical Systems, Inc. — 5 clearances
- Miles Laboratories, Inc. — 4 clearances
- Lkb Instruments, Inc. — 1 clearance
- Sakura Finetek U.S.A., Inc. — 1 clearance
- Technicon Instruments Corp. — 1 clearance
