HIVOX BIOTEK INC.— 510(k) K112392
Substantially EquivalentHivox Biotek, Inc.
FDA 510(k) clearance K112392 for HIVOX BIOTEK INC., Substantially Equivalent on 2012-03-19. Applicant: Hivox Biotek, Inc.. Device class: 2.
Clearance details
- Applicant
- Hivox Biotek, Inc.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsin-Chu City, TW
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