Cleared Traditional

VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT

K060168 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology
Apr 2006
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K060168 is an FDA 510(k) clearance for the VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 24, 2006, 91 days after receiving the submission on January 23, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K060168 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2006
Decision Date April 24, 2006
Days to Decision 91 days
Submission Type Traditional
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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