StatStrip Glucose Hospital Meter
FDA 510(k) clearance K150281 · decided 2015-05-06
Clearance details
- K-number
- K150281
- Device name
- StatStrip Glucose Hospital Meter
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-02-05
- Decision date
- 2015-05-06
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PZI
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.