K812157 is an FDA 510(k) clearance for the LKB-BROMMA 2218 HISTORANGE MICROTOME. This device is classified as a Microtome, Rotary (Class I - General Controls, product code IDO).
Submitted by Lkb Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981, 20 days after receiving the submission on July 29, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.3010.
| 510(k) Number | K812157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1981 |
| Decision Date | August 18, 1981 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | IDO — Microtome, Rotary |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3010 |