Strep B Carrot Broth One-Step— 510(k) K170586
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K170586 for Strep B Carrot Broth One-Step, Substantially Equivalent on 2017-05-22. Applicant: Hardy Diagnostics. Device class: 1.
Clearance details
- Applicant
- Hardy Diagnostics
- Product code
- Code PQZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.2360
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Maria, CA, US
Recent devices under product code PQZ
view allMore clearances from Hardy Diagnostics
view allRecalls naming K170586
K-number listed on FDA's recall record- Z-0441-2021 — Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
- Z-2051-2020 — Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170586.
Data sourced from openFDA. This site is unofficial and independent of the FDA.