ULTRAZYME PLUS AMYL— 510(k) K821869
Substantially EquivalentHarleco Diagnostics
FDA 510(k) clearance K821869 for ULTRAZYME PLUS AMYL, Substantially Equivalent on 1982-07-13. Applicant: Harleco Diagnostics. Device class: 2.
Clearance details
- Applicant
- Harleco Diagnostics
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Harleco Diagnostics
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