ANALYZER, SODIUM/POTASSIUM— 510(k) K791175
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K791175 for ANALYZER, SODIUM/POTASSIUM, Substantially Equivalent on 1979-08-10. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CEM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.