The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Indole Spot & Indole Kovacs Reagent.
| Device ID | K930718 |
| 510k Number | K930718 |
| Device Name: | INDOLE SPOT & INDOLE KOVACS REAGENT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Contact | Melissa M Taylor |
| Correspondent | Melissa M Taylor HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-11 |
| Decision Date | 1993-04-23 |