ARCHITECT TACROLIMUS: MODEL 1L77— 510(k) K070820
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K070820 for ARCHITECT TACROLIMUS: MODEL 1L77, Substantially Equivalent on 2007-08-01. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code MLM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1678
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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