Cleared Traditional

DBEST ONE-STEP OVULATION TEST

K974508 · Ameritek, Inc. · Chemistry
Feb 1998
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K974508 is an FDA 510(k) clearance for the DBEST ONE-STEP OVULATION TEST, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on February 2, 1998, 63 days after receiving the submission on December 1, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K974508 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1997
Decision Date February 02, 1998
Days to Decision 63 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

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