NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4— 510(k) K955252
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K955252 for NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4, Substantially Equivalent on 1996-02-02. Applicant: Nova Biomedical Corp.. Device class: 1.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.