NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS— 510(k) K884618
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K884618 for NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS, Substantially Equivalent on 1989-01-24. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code GKL
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code GKL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.