Cleared Traditional

FIRST RESPONSE OVULATION PREDICTOR TEST

K953581 · Armkel, LLC · Chemistry
Oct 1995
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K953581 is an FDA 510(k) clearance for the FIRST RESPONSE OVULATION PREDICTOR TEST, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on October 3, 1995, 63 days after receiving the submission on August 1, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K953581 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1995
Decision Date October 03, 1995
Days to Decision 63 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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