Amylase2— 510(k) K210633
Substantially EquivalentAbbott Ireland Diagnostics Division
FDA 510(k) clearance K210633 for Amylase2, Substantially Equivalent on 2022-05-26. Applicant: Abbott Ireland Diagnostics Division. Device class: 2.
Clearance details
- Applicant
- Abbott Ireland Diagnostics Division
- 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
- Longsford, IE
Recent devices under product code JFJ
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More clearances from Abbott Ireland Diagnostics Division
view allData sourced from openFDA. This site is unofficial and independent of the FDA.