ONE STEP HCG PREGNANCY TEST— 510(k) K062703
Substantially EquivalentAi DE Diagnostic Co., Ltd.
FDA 510(k) clearance K062703 for ONE STEP HCG PREGNANCY TEST, Substantially Equivalent on 2007-07-23. Applicant: Ai DE Diagnostic Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ai DE Diagnostic Co., 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
- Iowa City, IA, US
Recent devices under product code LCX
view all- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K251053 — Shinetell PlusTM Digital Early Pregnancy Test
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.