CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY— 510(k) K981931
Substantially EquivalentRoche Diagnostics/Boehringer Mannheim GmbH
FDA 510(k) clearance K981931 for CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY, Substantially Equivalent on 1998-08-25. Applicant: Roche Diagnostics/Boehringer Mannheim GmbH.
Clearance details
- Applicant
- Roche Diagnostics/Boehringer Mannheim GmbH
- Product code
- Code CGN
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.