IDO — Microtome, Rotary Class I
FDA product code IDO covers "Microtome, Rotary", a Class I medical device regulated under 21 CFR 864.3010. Submissions are reviewed by the Pathology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IDO
- Device Class
- Class I
- Regulation Number
- 864.3010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K864733 | lkb instruments | LKB 2260 MACROTOME | January 5, 1987 |
| K863548 | surgipath medical industries | ROTARY MICROTOME | September 19, 1986 |
| K843505 | lkb instruments | LKB 2230 ROTARY ONE | November 30, 1984 |
| K812558 | miles laboratories | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME | September 29, 1981 |
| K812157 | lkb instruments | LKB-BROMMA 2218 HISTORANGE MICROTOME | August 18, 1981 |