MAYBE?MOM MINI OVULATION MICROSCOPE— 510(k) K013582

Substantially Equivalent

Maybe?Mom

FDA 510(k) clearance K013582 for MAYBE?MOM MINI OVULATION MICROSCOPE, Substantially Equivalent on 2003-01-16. Applicant: Maybe?Mom. Device class: 1.

Clearance details

Applicant: Maybe?Mom
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 2001-10-30
Decision date: 2003-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, 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.