VERIFY PREGNANCY TEST KIT— 510(k) K840602

Name: FDA 510(k) clearance K840602
Creator: U.S. Food and Drug Administration
Published: 1984-03-19

Substantially Equivalent

O.T.C. Diagnostics, Inc.

FDA 510(k) clearance K840602 for VERIFY PREGNANCY TEST KIT, Substantially Equivalent on 1984-03-19. Applicant: O.T.C. Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: O.T.C. Diagnostics, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1984-02-10
Decision date: 1984-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCX

view all

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.