N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET— 510(k) K040241
Substantially EquivalentGenzyme Corp.
FDA 510(k) clearance K040241 for N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET, Substantially Equivalent on 2004-06-25. Applicant: Genzyme Corp.. Device class: 2.
Clearance details
- Applicant
- Genzyme Corp.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code DCK
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