The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Levofloxacin, 5mcg.
| Device ID | K002664 |
| 510k Number | K002664 |
| Device Name: | HARDYDISK LEVOFLOXACIN, 5MCG |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Contact | Melissa M Traylor |
| Correspondent | Melissa M Traylor HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-25 |
| Decision Date | 2000-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576020751 | K002664 | 000 |
| 00816576020744 | K002664 | 000 |