ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR— 510(k) K023407
Substantially EquivalentElan Diagnostics
FDA 510(k) clearance K023407 for ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR, Substantially Equivalent on 2003-02-14. Applicant: Elan Diagnostics.
Clearance details
- Applicant
- Elan Diagnostics
- Product code
- Code CGX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.