NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)— 510(k) K963005
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K963005 for NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE), Substantially Equivalent on 1996-08-23. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code JFL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code JFL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.