IEO — Processor, Tissue, Automated Class I
FDA product code IEO covers "Processor, Tissue, Automated", a Class I medical device regulated under 21 CFR 864.3875. Submissions are reviewed by the Pathology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IEO
- Device Class
- Class I
- Regulation Number
- 864.3875
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K924590 | innovative medical systems | MICROWAVE AUTOMATED TISSUE PROCESSOR | December 29, 1992 |
| K883599 | innovative medical systems | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | September 2, 1988 |
| K881165 | sakura finetek u.s.a | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | July 1, 1988 |
| K853938 | innovative medical systems | LX 300 TISSUE PROCESSOR | October 10, 1985 |
| K851054 | innovative medical systems | LX120 TISSUE PROCESSOR | May 15, 1985 |
| K843506 | lkb instruments | LKB 2189 ULTROPROCESSOR | November 30, 1984 |
| K834599 | technicon instruments | AUTOTECHNICON V TISSUE PROCESS SYS | February 4, 1984 |
| K831313 | miles laboratories | TISSUE-TEK V.I.P. 100/200 | July 28, 1983 |
| K801427 | miles laboratories | TISSUE-TEK III MINI-RAPID PROCESSOR | July 28, 1980 |
| K801513 | innovative medical systems | TISSUE PROCESSING SYSTEM | July 28, 1980 |
| K771308 | miles laboratories | TISSUE-TEK III V.I.P. | August 22, 1977 |
| K761062 | miles laboratories | HISTO-TEK W/ AUTOMATIC COVERSLIPPER | March 7, 1977 |