The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Gram - & Gram + Mic/combo & Breakpoint/combo Panel.
| Device ID | K874876 |
| 510k Number | K874876 |
| Device Name: | GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Todd A Woodring |
| Correspondent | Todd A Woodring 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 | 1987-11-30 |
| Decision Date | 1988-01-11 |