Strep B Carrot Broth Kit
FDA 510(k) clearance K170481 · decided 2017-05-16
Clearance details
- K-number
- K170481
- Device name
- Strep B Carrot Broth Kit
- Applicant
- Hardy Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2017-02-16
- Decision date
- 2017-05-16
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- PQZ
- Device class
- 1
- Regulation number
- 866.2360
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Maria, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Granada Medium (K173903) | Hardy Diagnostics | 2018-03-22 |
| Strep B Carrot Broth One-Step (K170586) | Hardy Diagnostics | 2017-05-22 |
| chromID Strepto B agar (K163042) | bioMerieux, Inc. | 2017-01-27 |
Recalls involving this device
No recalls on record reference this clearance.