One Step hCG Pregnancy Test— 510(k) K150063
Substantially EquivalentCoretests, Inc.
FDA 510(k) clearance K150063 for One Step hCG Pregnancy Test, Substantially Equivalent on 2015-10-02. Applicant: Coretests, Inc.. Device class: 2.
Clearance details
- Applicant
- Coretests, Inc.
- 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
- Carlsbad, CA, US
Recent devices under product code LCX
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- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
More clearances from Coretests, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.