AFFIRM ONE-STEP HOME PREGNANCY TEST— 510(k) K962888

Name: FDA 510(k) clearance K962888
Creator: U.S. Food and Drug Administration
Published: 1996-09-23

Substantially Equivalent

Athena Medical Corp.

FDA 510(k) clearance K962888 for AFFIRM ONE-STEP HOME PREGNANCY TEST, Substantially Equivalent on 1996-09-23. Applicant: Athena Medical Corp.. Device class: 2.

Clearance details

Applicant: Athena Medical Corp.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1996-07-24
Decision date: 1996-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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