The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Differentiation Disks Vancomycin 5 Mcg.
| Device ID | K860563 |
| 510k Number | K860563 |
| Device Name: | DIFFERENTIATION DISKS VANCOMYCIN 5 MCG |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| 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 | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-03-11 |