Cleared Traditional

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE

K062534 · Drg Intl., Inc. · Chemistry

Jan 2008

Decision

518d

Days

Class 1

Risk

About This 510(k) Submission

K062534 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE, a Radioimmunoassay, 17-hydroxyprogesterone (Class I — General Controls, product code JLX), submitted by Drg Intl., Inc. (East Stroudsburg, US). The FDA issued a Cleared decision on January 29, 2008, 518 days after receiving the submission on August 29, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number	K062534 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2006
Decision Date	January 29, 2008
Days to Decision	518 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement