STATSTRIP GLUCOSE HOSPITAL METER SYSTEM— 510(k) K132121
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K132121 for STATSTRIP GLUCOSE HOSPITAL METER SYSTEM, Substantially Equivalent on 2014-09-24. 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
- Traditional
- Location
- Walham, MA, US
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