Cleared Traditional

IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

K161082 · Immunodiagnostic Systems , Ltd. · Chemistry

May 2016

Decision

29d

Days

Class 1

Risk

About This 510(k) Submission

K161082 is an FDA 510(k) clearance for the IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on May 17, 2016, 29 days after receiving the submission on April 18, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K161082 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2016
Decision Date	May 17, 2016
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF