The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Aztreonam 30 Mcg Sensitivity Disks.
| Device ID | K870347 |
| 510k Number | K870347 |
| Device Name: | AZTREONAM 30 MCG SENSITIVITY DISKS |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | Robert |
| Correspondent | Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-28 |
| Decision Date | 1987-03-05 |