The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Strep B Carrot Broth One-step.
| Device ID | K170586 |
| 510k Number | K170586 |
| Device Name: | Strep B Carrot Broth One-Step |
| Classification | Gbs Culture Media, Selective And Differential |
| Applicant | Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Contact | Christopher Massey |
| Correspondent | Christopher Massey Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Product Code | PQZ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-28 |
| Decision Date | 2017-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819398026482 | K170586 | 000 |
| 00819398028516 | K170586 | 000 |
| 00819398028509 | K170586 | 000 |