StatStrip Xpress 2 Glucose Hospital Meter System— 510(k) K182549
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K182549 for StatStrip Xpress 2 Glucose Hospital Meter System, Substantially Equivalent on 2018-12-13. Applicant: Nova Biomedical Corporation. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corporation
- Product code
- Code PZI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Walham, MA, US
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