The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Pasco Mic And Mic/id Panels, Erythromycin.
| Device ID | K992647 |
| 510k Number | K992647 |
| Device Name: | PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
| Contact | Lindo K Dillon |
| Correspondent | Lindo K Dillon PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 1999-10-19 |
| Summary: | summary |