The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Remel Meropenem 10ug Susceptibility Disk.
| Device ID | K964421 |
| 510k Number | K964421 |
| Device Name: | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Mary A Silvius |
| Correspondent | Mary A Silvius REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-01 |
| Decision Date | 1996-12-06 |