The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Pasco Mic And Mic/id Panels, Gemifloxacin.
| Device ID | K031727 |
| 510k Number | K031727 |
| Device Name: | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
| Contact | Linda K Dillon |
| Correspondent | Linda K Dillon PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-03 |
| Decision Date | 2003-07-30 |
| Summary: | summary |