The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Vancomycin 5mcg Differential Disk.
| Device ID | K844382 |
| 510k Number | K844382 |
| Device Name: | VANCOMYCIN 5MCG DIFFERENTIAL DISK |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | ANAEROBE SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Marion E Cox |
| Correspondent | Marion E Cox ANAEROBE SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-01-04 |