ULTRAZYME PLUS ALP— 510(k) K821870
Substantially EquivalentHarleco Diagnostics
FDA 510(k) clearance K821870 for ULTRAZYME PLUS ALP, Substantially Equivalent on 1982-07-13. Applicant: Harleco Diagnostics.
Clearance details
- Applicant
- Harleco Diagnostics
- Product code
- Code CJE
- 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.