The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dried Gram Negative/cefmetazole.
| Device ID | K941317 |
| 510k Number | K941317 |
| Device Name: | DRIED GRAM NEGATIVE/CEFMETAZOLE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BAXTER DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Glorina J De Leon |
| Correspondent | Glorina J De Leon BAXTER DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-18 |
| Decision Date | 1995-01-31 |