The following data is part of a premarket notification filed by Micro-media Systems, Inc. with the FDA for Modified Fox Extra Gram Positive.
| Device ID | K945997 |
| 510k Number | K945997 |
| Device Name: | MODIFIED FOX EXTRA GRAM POSITIVE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | MICRO-MEDIA SYSTEMS, INC. 7194 OAKLAND MILLS RD. Columbia, MD 21045 |
| Contact | Maryalice Francisco |
| Correspondent | Maryalice Francisco MICRO-MEDIA SYSTEMS, INC. 7194 OAKLAND MILLS RD. Columbia, MD 21045 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-07 |
| Decision Date | 1995-02-16 |