K864733 is an FDA 510(k) clearance for the LKB 2260 MACROTOME. This device is classified as a Microtome, Rotary (Class I - General Controls, product code IDO).
Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 5, 1987, 32 days after receiving the submission on December 4, 1986.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3010.
| 510(k) Number | K864733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1986 |
| Decision Date | January 05, 1987 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IDO — Microtome, Rotary |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3010 |