LKC’s products are held to the highest standards of quality and compliance in the design, development, and manufacturing of equipment.
LKC Technologies is an ISO 13485:2016 / MDSAP certified corporation with FDA-registered medical device establishment with FDA 510(k) clearance on its products. LKC also has products installed worldwide with country specific medical device approvals where required. LKC’s devices are CE marked and FDA cleared. All LKC Electrophysiology Systems are RoHS compliant.
Warning: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Substance Tables:
The table below lists substances which may be contained within LKC’s RETeval and RETevet products. Substances listed as Type 1 are within permissible levels in one or more of LKC’s products. Substances listed as Type 2 are used in the production of some components used in LKC products and may be present at trace levels, but are typically destroyed during processing.
RETeval and RETevet Devices
| Substance | CAS # | Type | Listed as causing: |
| Nickel | 7440-02-0 | 1 | Cancer |
| Acrylonitrile | 107-13-1 | 2 | |
| Ethylbenzine | 100-41-4 | 2 | |
| Crystaline Silica | 14808-60-7 | 1 | |
| Lead | 7439-92-1 | 1 | Cancer Developmental Toxicity Male Reproductive Toxicity Female Reproductive Toxicity |
| Methylene Chloride | 75-09-2 | 2 | Cancer Female Reproductive Toxicity |
| Bisphenol A | 80-05-7 | 2 | |
| N-Hexane | 110-54-3 | 2 | Male Reproductive Toxicity |