The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardy Disk Ast Tigecycline 15 Ug, Modelz936.
| Device ID | K062245 |
| 510k Number | K062245 |
| Device Name: | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Contact | Andre Hsiung |
| Correspondent | Andre Hsiung 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 | 2006-08-02 |
| Decision Date | 2006-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576021109 | K062245 | 000 |