EVIDENCE PREGNANCY TEST— 510(k) K962721

Name: FDA 510(k) clearance K962721
Creator: U.S. Food and Drug Administration
Published: 1996-10-01

Substantially Equivalent

Saliva Diagnostic Systems

FDA 510(k) clearance K962721 for EVIDENCE PREGNANCY TEST, Substantially Equivalent on 1996-10-01. Applicant: Saliva Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Saliva Diagnostic Systems
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1996-07-15
Decision date: 1996-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Farms, MA, 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
K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette2025-02-13
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

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