Cleared Traditional

OIL FOR EMBRYO CULTURE

K011938 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology
Jul 2001
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K011938 is an FDA 510(k) clearance for the OIL FOR EMBRYO CULTURE, 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 July 18, 2001, 27 days after receiving the submission on June 21, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K011938 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2001
Decision Date July 18, 2001
Days to Decision 27 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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