The following data is part of a premarket notification filed by Micro-media Systems, Inc. with the FDA for Fox Fastidious Test Panels.
| Device ID | K953422 |
| 510k Number | K953422 |
| Device Name: | FOX FASTIDIOUS TEST PANELS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | MICRO-MEDIA SYSTEMS, INC. 2330 DENISON AVE. Cleveland, OH 44109 |
| Contact | Laura M Koeth |
| Correspondent | Laura M Koeth MICRO-MEDIA SYSTEMS, INC. 2330 DENISON AVE. Cleveland, OH 44109 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-07 |
| Decision Date | 1995-10-07 |