NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS— 510(k) K100602
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K100602 for NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS, Substantially Equivalent on 2011-08-17. Applicant: Nova Biomedical Corp.. Device class: 1.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code KHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1450
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
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