HOME PREGNANCY TEST KIT HPK #1— 510(k) K831051
Substantially EquivalentQuidel Corp.
FDA 510(k) clearance K831051 for HOME PREGNANCY TEST KIT HPK #1, Substantially Equivalent on 1983-05-18. Applicant: Quidel Corp.. Device class: 2.
Clearance details
- Applicant
- Quidel Corp.
- 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
- Washington, DC, US
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More clearances from Quidel Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.