The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Remel Piperacillin/tazobactam 100/10 Mcg.
| Device ID | K935975 |
| 510k Number | K935975 |
| Device Name: | REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Contact | Robert W Feiring |
| Correspondent | Robert W Feiring REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-09-19 |