The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Gentamicin, 10mcg.
| Device ID | K994091 |
| 510k Number | K994091 |
| Device Name: | HARDYDISK GENTAMICIN, 10MCG |
| 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 | 1999-12-03 |
| Decision Date | 2000-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576020690 | K994091 | 000 |
| 00816576020683 | K994091 | 000 |