ANSWER OVULATION TEST KIT— 510(k) K871241

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K871241 for ANSWER OVULATION TEST KIT, Substantially Equivalent on 1987-10-02. Applicant: Armkel, LLC. Device class: 1.

Clearance details

Applicant: Armkel, LLC
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1987-03-27
Decision date: 1987-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, 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.