The following data is part of a premarket notification filed by Lilly Research Laboratories with the FDA for Moxalactam.
Device ID | K822866 |
510k Number | K822866 |
Device Name: | MOXALACTAM |
Classification | Susceptibility Test Powders, Antimicrobial |
Applicant | LILLY RESEARCH LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JTT |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-27 |
Decision Date | 1982-12-28 |