510(k) K182549
K182549 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corporation for the device "StatStrip Xpress 2 Glucose Hospital Meter System". The FDA issued a decision of Substantially Equivalent on December 13, 2018. The device falls under product code PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing), a Class II device regulated under 21 CFR 862.1345. Nova Biomedical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2018
- Date Received
- September 17, 2018
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prescription Use Blood Glucose Meter For Near-Patient Testing
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.