GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT— 510(k) K772030
Substantially EquivalentHarleco
FDA 510(k) clearance K772030 for GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT, Substantially Equivalent on 1977-11-14. Applicant: Harleco. Device class: 1.
Clearance details
- Applicant
- Harleco
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- 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
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