The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Modified Fox Extra Gram Negative And Positive.
| Device ID | K896566 |
| 510k Number | K896566 |
| Device Name: | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | MEDICAL SPECIALTIES, INC. 2470 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Jerry L Cotton |
| Correspondent | Jerry L Cotton MEDICAL SPECIALTIES, INC. 2470 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-20 |
| Decision Date | 1990-02-09 |