K843505 is an FDA 510(k) clearance for the LKB 2230 ROTARY ONE. 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 November 30, 1984, 85 days after receiving the submission on September 6, 1984.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3010.
| 510(k) Number | K843505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1984 |
| Decision Date | November 30, 1984 |
| Days to Decision | 85 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 |