510(k) K893548— SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
Substantially EquivalentHeraeus Kulzer, Inc.
Clearance details
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- Code LBS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.