STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+— 510(k) K061830
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K061830 for STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+, Substantially Equivalent on 2006-11-01. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code CIG
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