ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,— 510(k) K093957
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K093957 for ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,, Substantially Equivalent on 2010-03-18. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code OIU
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code OIU
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