ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01— 510(k) K060818
Substantially EquivalentBiokit, S.A.
FDA 510(k) clearance K060818 for ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01, Substantially Equivalent on 2007-01-23. Applicant: Biokit, S.A..
Clearance details
- Applicant
- Biokit, S.A.
- Product code
- Code CDZ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
Data sourced from openFDA. This site is unofficial and independent of the FDA.