Processor, Tissue, Automated
An automated tissue processor is a laboratory instrument used in histopathology to carry out the sequential dehydration, clearing, and paraffin infiltration steps necessary to prepare excised tissue specimens for embedding and microtome sectioning, replacing manual processing. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IEO, regulated under 21 CFR 864.3875, in the Pathology medical specialty.
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Basic Information
- Product Code
- IEO
- Device Class
- FDA class 1
- Regulation Number
- 864.3875
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Dec 29, 1992 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Sep 02, 1988 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K881165 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | Jul 01, 1988 | Substantially Equivalent | Sakura Finetek U.S.A., Inc. |
| K853938 | LX 300 TISSUE PROCESSOR | Oct 10, 1985 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K851054 | LX120 TISSUE PROCESSOR | May 15, 1985 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K843506 | LKB 2189 ULTROPROCESSOR | Nov 30, 1984 | Substantially Equivalent | Lkb Instruments, Inc. |
| K834599 | AUTOTECHNICON V TISSUE PROCESS SYS | Feb 04, 1984 | Substantially Equivalent | Technicon Instruments Corp. |
| K831313 | TISSUE-TEK V.I.P. 100/200 | Jul 28, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K801513 | TISSUE PROCESSING SYSTEM | Jul 28, 1980 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K801427 | TISSUE-TEK III MINI-RAPID PROCESSOR | Jul 28, 1980 | Substantially Equivalent | Miles Laboratories, Inc. |
| K771308 | TISSUE-TEK III V.I.P. | Aug 22, 1977 | Substantially Equivalent | Miles Laboratories, Inc. |
| K761062 | HISTO-TEK W/ AUTOMATIC COVERSLIPPER | Mar 07, 1977 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.