SELFCARE EARLY PREGNANCY TEST— 510(k) K955903
Substantially EquivalentCambridge Diagnostics Ireland, Ltd.
FDA 510(k) clearance K955903 for SELFCARE EARLY PREGNANCY TEST, Substantially Equivalent on 1996-03-06. 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
- Traditional
- Location
- Galway, IE
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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.