The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Gram Positive Dried Overnight Panels/lomeflox.
| Device ID | K941459 |
| 510k Number | K941459 |
| Device Name: | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Elaine K Catapane |
| Correspondent | Elaine K Catapane BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1995-02-03 |