CYBOW READER, MODELS 300 & 720— 510(k) K102188
Substantially EquivalentDFI Co., Ltd.
FDA 510(k) clearance K102188 for CYBOW READER, MODELS 300 & 720, Substantially Equivalent on 2011-08-09. Applicant: DFI Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- DFI Co., Ltd.
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gangnam-Gu, Seoul, KR
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