The following data is part of a premarket notification filed by Microscan Div. Baxter Healthcare Corp. with the FDA for Gram Negative And Gram Positive Mic/combo Panels.
| Device ID | K870074 |
| 510k Number | K870074 |
| Device Name: | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Contact | Lorraine Weaver |
| Correspondent | Lorraine Weaver MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. 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 | 1987-01-08 |
| Decision Date | 1987-04-14 |