DIAZYME HOMOCYSTEINE POC TEST KIT— 510(k) K121053
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K121053 for DIAZYME HOMOCYSTEINE POC TEST KIT, Substantially Equivalent on 2012-07-31. Applicant: Diazyme Laboratories.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code LPS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.