K811573
Substantially EquivalentCARDIOZYME PLUS CK-MB ITEM #65045
- Applicant
- Harleco
- Product code
- JHW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.