NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH— 510(k) K101633
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K101633 for NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH, Substantially Equivalent on 2010-08-27. 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.