ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10— 510(k) K060359
Substantially EquivalentDenka Seiken Co., Ltd.
FDA 510(k) clearance K060359 for ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10, Substantially Equivalent on 2006-04-14. Applicant: Denka Seiken Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Denka Seiken Co., Ltd.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Gosen-Shi, Niigata, JP
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