510(k) K170481
K170481 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "Strep B Carrot Broth Kit". The FDA issued a decision of Substantially Equivalent on May 16, 2017. The device falls under product code PQZ (Gbs Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Hardy Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2017
- Date Received
- February 16, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gbs Culture Media, Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type
Culture Medium for GBS Detection