FACT PLUS PREGNANCY TEST— 510(k) K964108

Name: FDA 510(k) clearance K964108
Creator: U.S. Food and Drug Administration
Published: 1996-11-18

Substantially Equivalent

Direct Access Diagnostics

FDA 510(k) clearance K964108 for FACT PLUS PREGNANCY TEST, Substantially Equivalent on 1996-11-18. Applicant: Direct Access Diagnostics. Device class: 2.

Clearance details

Applicant: Direct Access Diagnostics
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1996-10-15
Decision date: 1996-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgewater, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCX

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K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test2025-09-09
K251053 — Shinetell PlusTM Digital Early Pregnancy Test2025-07-15
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K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream2025-01-31
K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more2025-01-15

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Data sourced from openFDA. This site is unofficial and independent of the FDA.