Cleared Traditional

PRO-STEP LH OVULATION PREDICTION TEST

K943252 · Disease Detection International, Inc. · Chemistry
Oct 1994
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K943252 is an FDA 510(k) clearance for the PRO-STEP LH OVULATION PREDICTION TEST, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on October 25, 1994, 111 days after receiving the submission on July 6, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K943252 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1994
Decision Date October 25, 1994
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

Similar Devices — CEP Radioimmunoassay, Luteinizing Hormone

All 142
MAYBE?MOM MINI OVULATION MICROSCOPE
K013582 · Maybe?Mom · Jan 2003
INSTANT-VIEW LH OVULATION PREDICTING TEST
K022829 · Alfa Scientific Designs, Inc. · Nov 2002
AT HOME OVULATION TEST, MODEL 9032
K021409 · Phamatech, Inc. · May 2002
CLEARPLANE EASY OVULATION TEST
K013874 · Unipath , Ltd. · Feb 2002
TCI-31 LIFELONG OVULATION TESTER
K013323 · Tci New York · Dec 2001
QUIK-CHECK OVULATION PREDICTOR
K012252 · ACON Laboratories, Inc. · Aug 2001