Cleared Traditional

SURE CHECK OVULATION PREDICTOR

K010244 · Chembio Diagnostic Systems, Inc. · Chemistry
May 2001
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K010244 is an FDA 510(k) clearance for the SURE CHECK OVULATION PREDICTOR, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Chembio Diagnostic Systems, Inc. (Beverly, US). The FDA issued a Cleared decision on May 2, 2001, 97 days after receiving the submission on January 25, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K010244 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2001
Decision Date May 02, 2001
Days to Decision 97 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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