The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lkb-bromma 2218 Historange Microtome.
| Device ID | K812157 |
| 510k Number | K812157 |
| Device Name: | LKB-BROMMA 2218 HISTORANGE MICROTOME |
| Classification | Microtome, Rotary |
| Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IDO |
| CFR Regulation Number | 864.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-29 |
| Decision Date | 1981-08-18 |