Cleared Traditional

MAYBE?MOM MINI OVULATION MICROSCOPE

K013582 · Maybe?Mom · Chemistry
Jan 2003
Decision
443d
Days
Class 1
Risk

About This 510(k) Submission

K013582 is an FDA 510(k) clearance for the MAYBE?MOM MINI OVULATION MICROSCOPE, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Maybe?Mom (Ramsey, US). The FDA issued a Cleared decision on January 16, 2003, 443 days after receiving the submission on October 30, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K013582 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2001
Decision Date January 16, 2003
Days to Decision 443 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEP — Radioimmunoassay, Luteinizing Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1485

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