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 |