RETeval
GUDID 00857901006323
Visual Electrophysiology passive sensing electrode
L K C TECHNOLOGIES, INC.
Electroretinograph electrode| Primary Device ID | 00857901006323 |
| NIH Device Record Key | dcb45071-ecff-47da-a7ee-1de2780d0b59 |
| Commercial Distribution Discontinuation | 2019-10-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | RETeval |
| Version Model Number | Samll Sensor Strips |
| Company DUNS | 606234730 |
| Company Name | L K C TECHNOLOGIES, INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857901006316 [Unit of Use] |
| GS1 | 00857901006323 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142567
FDA Product Code
| GXY | Electrode, Cutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-25 |
| Device Publish Date | 2019-09-16 |
Devices Manufactured by L K C TECHNOLOGIES, INC.
| 00857901006620 - RETeval™ | 2025-07-09 RETeval visual electrophysiology system - Complete Model for Ukraine only |
| 00857901006637 - RETeval™ | 2025-07-09 RETeval visual electrophysiology system - DR model for non-USA |
| 00857901006347 - UTAS | 2025-06-17 |
| 00857901006002 - RETeval™ | 2023-07-06 Bag of 10 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system. |
| 00857901006491 - UTAS | 2022-07-05 |
| 00857901006507 - UTAS | 2022-07-05 |
| 00857901006514 - UTAS | 2022-07-05 |
| 00857901006521 - UTAS | 2022-07-05 |
Trademark Results [RETeval]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RETEVAL 85609540 4332869 Live/Registered |
LKC Technologies, Inc. 2012-04-26 |
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