Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls— 510(k) K140654
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K140654 for Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls, Substantially Equivalent on 2015-05-22. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code PDJ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.