INVERNESS MEDICAL EARLY PREGNANCY TEST— 510(k) K013907
Substantially EquivalentCambridge Diagnostics Ireland, Ltd.
FDA 510(k) clearance K013907 for INVERNESS MEDICAL EARLY PREGNANCY TEST, Substantially Equivalent on 2001-12-18. Applicant: Cambridge Diagnostics Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cambridge Diagnostics Ireland, Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
Recent devices under product code LCX
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More clearances from Cambridge Diagnostics Ireland, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.