The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Ceftolozane/tazobactam, (30/10ug)- C/t40.
| Device ID | K152846 |
| 510k Number | K152846 |
| Device Name: | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LANE Santa Maria, CA 93455 |
| Contact | Wendy Hadley |
| Correspondent | Wendy Hadley HARDY DIAGNOSTICS 1430 WEST MCCOY LANE 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 | 2015-09-29 |
| Decision Date | 2015-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576022045 | K152846 | 000 |
| 00816576022038 | K152846 | 000 |