The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Dried Gram-negative And Positive Mic/combo Panels.
| Device ID | K922458 |
| 510k Number | K922458 |
| Device Name: | DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Karla Tomfohrde |
| Correspondent | Karla Tomfohrde BAXTER HEALTHCARE CORP. 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 | 1992-05-26 |
| Decision Date | 1992-12-11 |