Microtome, Rotary
A rotary microtome is a laboratory instrument used in histopathology to produce thin, uniform sections of paraffin-embedded tissue for mounting on glass slides and subsequent staining and microscopic examination. 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 IDO, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.
Basic Information
- Product Code
- IDO
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K864733 | LKB 2260 MACROTOME | Jan 05, 1987 | Substantially Equivalent | Lkb Instruments, Inc. |
| K863548 | ROTARY MICROTOME | Sep 19, 1986 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K843505 | LKB 2230 ROTARY ONE | Nov 30, 1984 | Substantially Equivalent | Lkb Instruments, Inc. |
| K812558 | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME | Sep 29, 1981 | Substantially Equivalent | Miles Laboratories, Inc. |
| K812157 | LKB-BROMMA 2218 HISTORANGE MICROTOME | Aug 18, 1981 | Substantially Equivalent | Lkb Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.