Cleared Abbreviated

INSTANT-VIEW LH OVULATION PREDICTING TEST

K022829 · Alfa Scientific Designs, Inc. · Chemistry
Nov 2002
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K022829 is an FDA 510(k) clearance for the INSTANT-VIEW LH OVULATION PREDICTING TEST, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on November 5, 2002, 71 days after receiving the submission on August 26, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K022829 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2002
Decision Date November 05, 2002
Days to Decision 71 days
Submission Type Abbreviated
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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