PREGNANCY TEST KIT, ANSWER— 510(k) K772359

Name: FDA 510(k) clearance K772359
Creator: U.S. Food and Drug Administration
Published: 1978-01-05

Substantially Equivalent

Diagnostic Testing, Inc.

FDA 510(k) clearance K772359 for PREGNANCY TEST KIT, ANSWER, Substantially Equivalent on 1978-01-05. Applicant: Diagnostic Testing, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Testing, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1977-12-27
Decision date: 1978-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

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K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more2025-01-15

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