The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cybrex Lidocaine.
| Device ID | K802131 |
| 510k Number | K802131 |
| Device Name: | CYBREX LIDOCAINE |
| Classification | Enzyme Immunoassay, Lidocaine |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | KLR |
| CFR Regulation Number | 862.3555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-04 |
| Decision Date | 1980-10-31 |