AP3600 Automated Instrument— 510(k) K182793
Substantially EquivalentHitachi Chemical Diagnostics, Inc.
FDA 510(k) clearance K182793 for AP3600 Automated Instrument, Substantially Equivalent on 2019-03-19. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Chemical Diagnostics, Inc.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
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