Cleared Special

Sydney IVF Sperm Cryopreservation Buffer

K160814 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Apr 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K160814 is an FDA 510(k) clearance for the Sydney IVF Sperm Cryopreservation Buffer, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on April 22, 2016, 29 days after receiving the submission on March 24, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K160814 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2016
Decision Date April 22, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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